GMP Guidelines and News Updates

Conferment of QCI - D.L. Shah National Quality Award to IGMPI

Hon'ble Dr GN Singh, Drug Controller General of India presented a Momento by IGMPI on the launch of our Computer Validation (CSV) program

Dr. APJ Kalam,Hon'ble Former President releasing our Lab World Magazine with our Principal Advisor, Editor Dr Mahesh Gupta

Hon'ble Prime Minister of India, Shri Narendra Modi congratulating Media Advisor, IGMPI- Shri Samir Abbas on his initiative

Conferment of ASSOCHAM Services Excellence Award 2017 to IGMPI

IGMPI honoured as the Jury (yet again) for the FDD Leadership Awards

FDD Leadership Awards 2018 Conferment by Mr Vinod Arora, Principal Advisor, IGMPI

Mr Vinod Arora, Principal Advisor, IGMPI (Moderator)

Whose work ideology revolves around its sole vision to make available efficient professionals to the Industry

Targeting to fill up the gap between the existing and accessible knowledge

Whose work ideology revolves around its sole vision to make available efficient professionals to the Industry

With the values of Quality, Flexibility, Excellence and Professionalism

Whose work ideology revolves around its sole vision to make available efficient professionals to the Industry

Targeting to fill up the gap between the existing and accessible knowledge

Educating todays learners for tomorrows world

Whose work ideology revolves around its sole vision to make available reliable and efficient professionals to the Industry

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FSSAI Food Safety Training, HACCP & FSMS training by IGMPI

GLOBALG.M.P.™ Newsletter

23^rd July 2019 Complete compliance followed in Patanjali; denial receiving USFDA notice Baba Ramdev said that company follows complete compliance as per the ayurvedic specifications of India and US. The company has zero-tolerance policy in response to quality concerns.
22^nd July 2019 USFDA said Patanjali’s sharbat bottles contains different dietary, medical claims According to the USFDA, the labels on Patanjali’s two sharbat bottles, sold within India, were found to be having “additional medicinal and dietary market claims” as compared to the ones meant for export to America. They also found out that the production and packaging area for exported products is separate from the domestic products.
20^th July 2019 7 USFDA Observations to Cipla's Bengaluru API Unit The USFDA has issued seven observations to the Bengaluru facility of Cipla. A routine cGMP inspection was carried out by the USFDA to the API facility of Cipla based at Bengaluru.
16^th July 2019 Strides Pharma Warned by FDA over Uncontrolled Document Shredding Earlier this month, the USFDA warned Indian generic drugmaker Strides Pharma over good manufacturing practice (GMP) violations at its Pondicherry facility. uncontrolled shredding of documents and inadequate investigations in out-of-specification (OOS) test results were some the major violations observed by the USFDA inspectors.
15^th July 2019 Indoco Remedies received warning letter for oral dosage plant The US FDA warning letter is issued to Indoco Remedies for its Oral Dosage Plant-1, Goa following an inspection in January 2019. The facility has classified as Official Action Indicated (OAI) in March 2019 after receiving Form 483 with 6 observations. The remediation activities for the observations is still going on in the facility.
15^th July 2019 NATCO pharma completes US FDA inspection with zero observations The Natco pharma has successfully completed with the US FDA audit of their Chennai based facility. The audit was done for the active pharmaceutical ingredient facility between 8 July-12 July 2019.
12^th July 2019 5 US FDA Observations to Hyderabad plant of Dr Reddy’s A form 483 stating the objectionable conditions was issued to Dr. Reddy’s laboratory plant based at Hyderabad. The US FDA has audited their active pharmaceutical ingredient (API) manufacturing plant 2 at Bollaram, Hyderabad resulting into form 483 with 5 observations.
12^th July 2019 US FDA nod to Laurus Labs The Laurus Labs has successfully completed the US FDA audit of their Visakhapatnam’s Unit 4 facility without any Form 483. The audit was done between 8 July – 12 July 2019.
09^th July 2019 Revised REMS Modification Guidance Finalized by FDA The US FDA finalized a revised guidance on making and submitting modifications and revisions to risk evaluation and mitigation strategies (REMS), including what types of changes FDA will consider and processes and procedures for submitting those changes to the FDA.
09^th July 2019 Akron warned for repeated Violations The US FDA released a warning letter for Akron’s Somerset, New Jersey manufacturing facility due to the violations of cGMP. The letter included all the observations the FDA inspection team made during their one-month inspection last month.
09^th July 2019 FDA to Pull 31 Apotex ANDAs Due to Manufacturing Concerns The US FDA announced that they are withdrawing the approval of 31 abbreviated new drug applications (ANDAs) held by Apotex after they found the manufacturing deficiencies at two of the company’s plants.
02^nd July 2019 USFDA Warning letter to Aurobindo Indian Drug maker, Aurobindo Pharma received a warning letter from the FDA about violations of good manufacturing practice (GMP) at one of the company’s facilities in Srikakulam District, Andhra Pradesh following a six-day inspection in February.
20^th June 2019 Voluntary Recall of All Sterile Products Issued by Infusion Options Inc. Infusion Options Inc. has decided to recall all sterile products lots within expiry date due to lack of sterility assurance. Till date, the company has not received any adverse event report but administration of sterile products whose sterility is not assured can be life-threatening.
14^th June 2019 Adulterated products from Life Rising Corporation seized by FDA officials More than 300,000 dietary supplement containers, including tablets, capsules and teas from Life Rising Corporation were seized by the U.S. FDA officials. The products were seized from company’s Willowbrook, Illinois, manufacturing facility, consisted of hundreds of goods bearing brand names Holicare, or Life Rising, and their value is around $3.5 million.
11 June 2019 Taiwan Drug manufacturer gets the US FDA warning over GMP violations The US FDA warned Taiwan-based Drug manufacturer, Vida International following an inspection at Taoyuan city facility last December over GMP non-compliance and placed Vida on import alert in March. In the warning letter, the US FDA states that Vida has not conducted batch testing for one of its products before release.
22 May 2019 Curam Duo 400-57 Recall: TGA Australia The TGA Australia has instructed Sandoz Australia to recall two batches of Curam Duo 400/57- JC5418 and JC5419. Curam Duo contains amoxicillin and potassium clavulunate. It is an oral suspension in powder form which is used to treat bacterial infections in children and adults.
21 May 2019 Liver injury risk leads to Hairpro capsules and hair tonic recall A safety investigation done by the TGA Australia results in the recall of Oriental Botanicals Hairpro capsules and Fusion Hair Tonic because of liver injury risk.
07 May 2019 Warning letter for cGMP non-compliance to Canadian OTC manufacturer Petra Hygienic Systems Int. Ltd. received US FDA warning letter for violating cGMP practices. Their facility based in Concord, Ontario was failed to validate outsourced material and test products for the strength and identity of API. They also did not have appropriate written cleaning procedures in place.
22 March 2019 Alkem's Product Approval withhold by USFDA A pre approval inspection was done at St. Louis manufacturing of Alkem Dated 06 February 2019.
18 March 2019 FDA AUDITS IN INDIA AND OAI Inspection standards of the FDA were same since last 15 years, only the audit frequency has changed. The number of FDA inspections has increased in recent years due to several reasons such as more applications for Abbreviatived New Drug Applications which demand inspection for each filing and GDUFA fee where applicants pay to FDA to get the inspection done. It has been observed that Indian companies are not improving their quality even after getting observations from FDA.
06 March 2019 Form 483 to Biocon, Bengaluru facili USFDA has given 6 observations in Form 483 to Biocon followed by its Bengaluru plant inspection. A New Drug Application for insulin was submitted by the firm to FDA. Approval of which requires pre-inspection audit resulting into these six observations.
06^th March 2019 Roorkee facility of Jubilant Life Science gets warning letter from USFDA A warning letter has been issued to Jubilant Life Sciences, Roorkee facility based in Uttarakhand. It has been told by the officials of Jubilant Life Sciences that this warning letter can leads to withhold of several new application approvals until all the issues will be addressed by the company. The inspection was done from 30 July 2018 to 08 August 2018. cGMP regulations with respect to finished pharmaceuticals were violated at the facility as per FDA officials.
04 March 2019 Warning letter issued to Hospira, India Facility Data integrity issues along with cGMP violations in Hospira, India facility leads them to receive a warning letter by FDA Dated 04 March 2019. FDA inspected the Tamil Nadu’s Hospira facility from 27 March to 03 April 2018. Several cGMP violations have been observed during the inspection ranging from data integrity issues to unacceptable batch failure investigations.
28^th February 2018 USFDA warning letter to Anicare Pharmaceuticals The FDA inspection at Navi Mumbai facility of Anicare Pharmaceuticals was done during 30 July 2018 to 03 August 2018. The company has received warning letter following this audit due to cGMP violations at their facility for finished pharmaceuticals.
18^th December 2018 Draft Guidance on Good practices for Integrity and Data Management framed by PIC/S The Pharmaceutical inspection convention/Pharmaceutical inspection cooperation scheme (PIC/S) has released a draft guidance of 53 pages describing that how an inspector should examine facilities that must follow Good Manufacturing Practices (GMP) and Good distribution practice (GDP). This draft was released keeping in mind the violations of data integrity that are continuously found in FORM 483s and warning letters.
18^th December 2018 Regulatory action after Jubilant Life’s Roorkee Plant survey suggested by USFDA As per a regulatory filing, a supervisory action has been suggested by US health regulator after completion of the examination of Roorkee manufacturing facility of drug firm Jubilant Life Sciences.
18^th December 2018 Guidelines on quality of water for pharmaceutical use published by EMA Draft guidance has been published by EMA on quality of water that has to be used for the pharmaceutical purpose. This draft will provide direction to the industry. This draft is aimed at providing knowledge about the pharmaceutical utilization of different grades of water used in manufacturing medicinal product and active substances for veterinary and human use. The methods which are parallel to the water distillation will be included in this draft.
18^th December 2018 USFDA EIR obtained by Lupin for unit 3 of the Pithampur facility An EIR (Establishment Inspection Report) form the U.S regulator has been received for unit 3 facility in Madhya Pradesh of Lupin limited, which is a multinational pharmaceutical company based in Mumbai.
06^th December 2018 Biocon's Bengaluru Plant's Inspection Completed By Usfda The inspection of the new manufacturing facility of Biocon was completed by USFDA without any findings.
06^th December 2018 Alkem Lab Taloja Facility’s Inspection By Usfda Comes To An End Review of Alkem Lab's Bioequivalence facility located at Taloja in the state of Maharashtra has been completed by USFDA (United State Food and Drug Administration) from 8th to 14th November 2018. No form 483 was issued at the end of it.
23^rd November 2018 GMP Violation noted by FDA at US vascular medical device manufacturing unit As per the reports, during an inspection of US vascular's medical device manufacturing facility at Beaverton by US FDA, there have been 11 contraventions of good manufacturing practices, as per a FDA warning letter.
15^th November 2018 ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products Continuous manufacturing can improve manufacturing of drug products and drug substances. However, its commercialization is challenging due to insufficient regulatory guidelines. Therefore, development of ICH guideline could support in minimizing such barriers. This can help in development of common regulatory concepts, definitions, processes, etc. Q13 final concept paper regarding continuous manufacturing was enforced Dated 15 November 2018. The new guideline will address regulatory expectations such as site implementation, post-approval changes and quality systems.
14^th November 2018 ICH Q14: Analytical Procedure Development and Revision of Q2 (R1) Analytical Validation Final concept paper regarding ICH Q14 was issued dated 14 November 2018. It has been proposed that Q2 (R1) must be revised along with development of a new guideline based on development of Analytical Procedure. This can help in harmonization of requirements and improvise the communication amongst regulators and industry. Harmonization is required for several scientific and technical elements involving development of analytical procedure and its submission along with required information in CTD format.
14^th September 2018 Warning Letter issued by USFDA to subsidiary of Zimmer Biomet Holdings Inc. for cGMP violations Zimmer Biomet has received warning letter from USFDA for its North Campus manufacturing facility located in Warsaw Indiana due to current good manufacturing practice non-conformities of its quality system.
14^th September 2018 USFDA issued form 483 to Halol Facility of Sun Pharma on account of cGMP violations Sun Pharma's Halol Facility located in Gujarat has received form 483 on account of cGMP violations. The USFDA conducted a pre-approval inspection (PAI) of the Halol facility and found non-compliance with cGMP regulations. The inspection was carried out from 27th August 2018 to 31ST August 2018.
14^th September 2018 USFDA released an internal procedure on prioritization of inspection of manufacturing facilities An internal Manual of Policies and Procedures called MAPP had been released by USFDA which reveals how pharmaceutical manufacturing sites are prioritized and selected for surveillance inspections.
14^th September 2018 The Lupin’s Tarapur API facility received one observation on account of cGMP deficiency Lupin is India’s third largest drug manufacturing company. The Tarapur API manufacturing facility of Lupin has received one observation by USFDA. The Tarapur facility produces fermentation based APIs.
14^th September 2018 Anti-rabies vaccine from China recalled by USFDA on account of cGMP issues All batches of an-anti rabies vaccine imported from Jilin province in China have been recalled by USFDA after the National Medical Products Administration of China found that the anti-rabies vaccine manufacturer, Changchun Changseng Life Sciences Ltd violated relevant requirements of GMP. Mainly data integrity issues were observed.
14^th September 2018 Recall of hypertension drug bottles from US by Hetero Labs on account of cGMP issues Hetero Labs is recalling over 15.90 lakh bottles of Valsartan Tablets USP in the strengths of 40 mg, 80 mg, 160 mg and 320 mg from US market due to deviations from good manufacturing norms. The tablets were manufactured by the company for Camber Pharmaceuticals Inc.
06 July 2018 Guidance on Good Manufacturing Practice for APIs finalized by FDA The FDA has finalized the guidance on Good Manufacturing Practice (GMP) for active pharmaceutical ingredients (APIs) which is based on the International Conference on Harmonization (ICH Q7) guidelines. The revised guideline is based on question and answer format so that responses can be provided to requests for clarification of uncertainties due to interpretation of certain sections in the ICH guidance.
06 July 2018 Draft guidance released by FDA on Product tracing requirements A draft guidance namely “Standardization of Data and Documentation Practices for Product Tracing" has been released by FDA to help trade partners in standardizing the data needed for ensuring the traceability of products.
06 July 2018 First sANDA (Supplemental Abbreviated New Drug Application) approved by USFDA for Glenmark Pharmaceuticals Manufacturing Facility In Monroe, North Carolina Glenmark Pharmaceuticals Ltd. (GPL) is a global innovative pharmaceutical company with presence in more than 50 countries and has a diverse pipeline with several compounds in various stages of clinical development, primarily focused in the areas of oncology, respiratory disease and dermatology.
06 July 2018 FDA form 483 issued to Mylan Pharmaceuticals' manufacturing facility in Morgantown, WV for lapses in quality control Mylan Pharmaceuticals' manufacturing facility in Morgantown, WV, received an FDA Form 483 due to lapses in quality control and GMP violations. The FDA inspection of the site took place earlier this year and it was a 12 day inspection.
06 July 2018 EIR (Establishment Inspection Report) received by Sun Pharma for its Halol Facility in Gujarat The Halol manufacturing Facility of Sun Pharma was inspected way back in September 2014 by three USFDA inspectors Parul Patel, Daniel Roberts and Thomas Arista who began inspection of the facility on September 8, 2014 which continued till September 19, 2014 leading to 23 observations and 19 page Form 483.
06 July 2018 Henan Lihua Pharmaceutical Co. Ltd. Warned for GMP violations by USFDA Henan Lihua Pharmaceutical Co. Ltd is a Chinese Active Pharmaceutical Ingredient manufacturer which produces steroid and hormone APIs and is GMP-certified by regulators in the EU, US and China. The US Food and Drug Administration (FDA) has conducted the inspection of the company last December in which they found GMP violations and data integrity issues and therefore has given warning letter to the company.
06 July 2018 Chennai based BCG vaccine Laboratory to restart manufacture of multi-dose vials of anti-tuberculosis Chennai based BCG Vaccine Laboratory has applied to the directorate of drugs control for a commercial licence to restart manufacture of multi-dose vials of anti-tuberculosis after the experiment batches of the anti-tuberculosis vaccine manufactured in the company’s new building were declared consistent and of standard quality by the Central Drugs Laboratory in Kasauli. Six batches of the vaccine manufactured between January and March were tested and found to be of standard quality.
06 July 2018 Inspection by USFDA completed at Zydus Cadila,Ahmedabad plant Zydus Cadila is headquartered at Ahmedabad in Gujarat and is the fourth largest pharmaceutical company in India. It was founded in 1952 by Ramanbhai Patel, formerly a lecturer in the L.M. College of Pharmacy and his business partner Indravadan Modi. However in 1995, the Patel and Modi families split and Modi Family’s share moved into a new company called Cadila Pharmaceuticals Ltd. and Cadila Healthcare.
06 July 2018 USFDA issued warning letter to IDT Australia Limited’s facility on account of GMP violations Warning letter has been issued by USFDA to the Australian pharmaceutical company and contract development and manufacturing organization (CDMO) IDT Australia due to GMP violations. IDT Australia makes APIs and finished drug product s for clients. The company’s Boronia facility, Victoria was inspected by FDA in December 2017.
11^th June 2018 Pharma companies marketing medicines made by third parties in India shall be liable for any quality issues as per CDSCO A proposal was approved by The Drugs Technical Advisory Board (DTAB) recently to amend the Drugs & Cosmetics Act to make pharmaceutical marketing firms accountable for any violations of the regulations which means that companies marketing medicines in India will soon be as liable as the manufacturers for any violations of drug regulations that could lead to spurious or substandard medicines.
11^th June 2018 Two additional EU member states join EU-US Mutual Recognition Agreement to carry out Good Manufacturing Practice Two additional EU member states -Lithuania and Ireland have joined The US Food and Drug Administration (FDA) to carry out Good Manufacturing Practice inspections at a level equivalent to the US as confirmed by European Medicines Agency (EMA).
11^th June 2018 Draft Guideline for Handling and Shipping Investigational Medicines proposed by EMA opened for public consultation Two additional EU member states -Lithuania and Ireland have joined The US Food and Drug Administration (FDA) to carry out Good Manufacturing Practice inspections at a level equivalent to the US as confirmed by European Medicines Agency (EMA).
11^th June 2018 Complaint filed against two stem cell clinics by FDA in Federal Court FDA requires the stem cell treatments to be studied under an Investigational New Drug (IND) application and has discretion to approve and give a go ahead only on the basis of how the product is manufactured to ensure appropriate steps are being taken to assure the product’s safety, purity, and strength.
11^th June 2018 Inspection of JB Chemicals and Pharmaceuticals manufacturing facility at Panoli, Gujarat completed by USFDA J B Chemicals and Pharmaceuticals API manufacturing facility at Panoli, Gujarat has successfully passed periodical inspection by US Food and Drug Administration (USFDA). This US FDA/EU/Japan approved API facility primarily manufactures APIs for exports to EU and formulations exports to US.
23^rd May 2018 Reine Lifescience gets US FDA warning letter for contravention of cGMP norms for APIs Warning letter has been issued to Reine Life science by US Food and Drug Administration (FDA) on May 9, 2018. Reine Lifescience is a manufacturer of Active Pharmaceutical Ingredients (APIs) located in Gujarat.
24^th February 2018 Indian Pharma Stands Strong in Global markets In the Year 2017, Indian pharma companies received 29% USFDA warning letters as compared to 50% in the year 2015. The Indian pharma companies register marked improvement in quality standards and regulatory compliance.
24^th February 2018 UK MHRA Suggests Little Changes to Regulatory Framework The MHRA (Medicines and Healthcare products Regulatory Agency, UK) has released letter on the negotiations between the EU and the UK which have now in second phase.
24^th February 2018 Violation-of-GMP-Principles-at-Indian-API-Manufacturing-Unit Inspectors from Danish Medicines Agency inspected the facilities of Kadam Exports Private Ltd , an Indian API Manufacturers. The audit revealed severe deficiencies in the compliance with the GMP rules in virtually all areas. The active substance under scrutiny was Psyllium husk, a dietary and herbal medicinal product.
24^th February 2018 Health-ministry-constitutes-DTAB-sub-committee-to-re-examine-banneds Under the Government of India’s Union Health Ministry, a sub-committee is formed to examine the banned 344 FDCs + 5 FDCs as per the directions of the Supreme Court of India. The sub-committee will be headed by Dr NilimaKshirsagar
17^th January 2018 Collaboration between US FDA and Gujarat FDCA to Implement Joint Project Among top three aspects for collaboration- knowledge sharing, capacity building and raising compliance levels, the Gujarat Food and Drug Control Administration (FDCA) is planning to meet US Food and Drug Administration (FDA) officials.
17^th January 2018 India reports quality shortcomings of Chinese pharma companies In response to shortcomings Indian government has issued a showcause notices to eight Chinese pharmaceutical companies. Those companies were inspected by a special Indian inspection team and were found to supply poor quality APIs to drug manufacturers in India.
17^th January 2018 European Inspector Found Cleaning and Process Validation Deficiencies US FDA publishes GMP deficiencies in their warning Letter in Form 483. In European Union, there is a European portal, where non-compliance results are published.
17^th January 2018 Missing Tests for Identity lead to FDA Warning Letter A Canadian manufacturer, Cellex-C International, Inc received a FDA Warning Letter issued on August, 2017 basis an FDA inspection.The inspection team lamented that not all batches of the manufactured drug product and the active substances used therein had been tested for compliance with the specifications before their release. According to the response given by Cellex-C, the tests had been performed by a contract laboratory.
28^th December 2017 The Maharashtra FDA Issues Suspension of Licenses Basis Non-Compliance Over the past six months, Maharashtra Food and Drug Administration (FDA) has cancelled 278 retail licenses and suspended 1,439 licenses across the state for non-compliance to Drugs and Cosmetics Act. This action is an outcome of state drug regulator’s routine inspections on drug retail shops and 2908 wholesale inspections.
28^th December 2017 Dr. Reddy’s exhibits promising growth prospects as regulatory concerns subside In the last one-two years Dr. Reddy’s Laboratories Ltd has faced deteriorating earnings profile, however, the scenario now seems to improve due to easing regulatory concerns and expected launch of certain high-value products in the US.
28^th December 2017 Long Awaited Draft to Annex 1 on Sterile Manufacturing Published The European Commission has released the long awaited draft of Annex 1 “Manufacture of Sterile Medicinal Products”. The draft is open for public consultation from 20 December 2017 until 20 March 2018.
28^th December 2017 Non-Compliance ASU&H Drug Manufacturers In a statement released by Government of India, out of 8,667 licenced Ayurvedic, Siddha, Unani and Homoeopathy (ASU&H) drug manufacturers in the country, 1179 are reported to be non-compliant with the prescribed Good Manufacturing Practices (GMP).
16^th December 2017 Biocon, Mylan Gets US Approval for Ogivri- Biosimilar for Trastuzumab US Food and Drugs Administration (USFDA) have provided approval to Biocon and Mylan for its biosimilar Herceptin or trastuzumab, Ogivri. Ogivri has been approved for all indications included in the label of the reference product, Herceptin.....
16^th December 2017 Glenmark is Served With Form 483 at its Baddi Plant, Himachal Pradesh The US Food and Drugs Administration (FDA) has served Glenmark, an Indian manufacturer, Form 483 citing observations relating to violation of good manufacturing practices which the inspectors noticed while inspecting the Baddi Plant.
16^th December 2017 GMP Deficiencies in Vital Laboratories Limited In pharmaceutical Industry, GMP violations are unacceptable and depict a manufacturer’s lax handling of deviations, insufficient monitoring and documentation of critical process steps as well as their ignoring of OOS results in quality control. In April 2017, FDA inspectors were confronted with these violations when they visited the production site of an Indian manufacturer Vital Laboratories Private Limited
16^th December 2017 German Regulatory Agency Permits Dr Reddy’s Visakhapatnam Plant to Restart Exports to EU In a recent development, Reddy’s Laboratories Ltd has got permission from German regulatory authority for its Visakhapatnam plant to restart production for the European market (EU). The corrective and preventive action plan (CAPA) submitted by Dr. Reddy’s has been well accepted by the regulator. Consequently, the regulator has permitted production to start again from this facility for the EU market. However, an inspection will be conducted by the regulator by the end of 2018.
16^th December 2017 European Medicine Agency’s New Location: Amsterdam The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken after the voting of EU 26 Member States. The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest.
16^th December 2017 New GMP Guidelines for Advanced Therapies Released by European Commission The European Commission has published a set of guidelines on good manufacturing practice (GMP) specific to advanced therapy medicinal products (ATMPs). New advanced medicinal therapies are based on medicines for human use that involve genes or cells. These therapies offer ground-breaking new.
06^th October 2017 DIVI’s LABS gets USFDA FORM 483 Following inspection of Unit-2 at Vishakhapatnam for API manufacturing, USFDA has found more problems at Divi’s Laboratories Limited that was earlier banned from shipping to the US in March 2017......
06^th October 2017 EMA releases Question/ Answer document to lift a non-compliance statement New process has been outlined by The European Medicines Agency (EMA)on lifting a GMP non-compliance statement. The new process will facilitate understanding on how to proceed further following a receipt of non-compliance certificate on GMP of the EMA.
06^th October 2017 Pharma Exports are led by Gujarat with highest number of 280 WHO-GMP certified manufacturing units followed by Maharashtra Gujarat has achieved the distinction of having the highest number of 280 WHO – GMP certified manufacturing units in the country followed by Maharashtra with 222 units, Himachal Pradesh at 134, Telangana at 131 and Uttarakhand at 97.
09^th September 2017 DRL’s Bachupally unit failed to get GMP Nod from German Regulator Dr Reddy’s Laboratories Bachupally Unit 2 failed to get Good Manufacturing Practices (GMP) compliance certificate from German Regulator. Only this time it has run afoul of the German regulator Regulatory Authority of Germany (Regierung von Oberbayern)......
09^th September 2017 Maharashtra FDA cancels 58 MFG licenses and suspends 145 licenses for GMP non-compliance In a recent attempt to scrutinize and curb malpractices in Good Manufacturing Processes, Maharashtra FDA cancelled 58 manufacturing licenses and suspended 145 licenses of manufacturing units across the state since April 2016 till date The strict action taken by Maha FDA is response to malpractices followed
09^th September 2017 DCGI demands stability data for Non-Patented and Proprietary Drugs In order to maintain quality of drugs, the Drugs Controller General of India (DCGI) has directed all the drug manufacturers to submit the stability data of non-patent and proprietary medicines. At the time of submission of application for grant of permission to manufacture medicines, the manufacturer will now submit stability data of non-patent and proprietary
09^th September 2017 Hetero Labs gets USFDA Warning Letter Hyderabad based Hetero labs received a warning letter from US FDA for serious violation of current Good Manufacturing Practices (cGMP) following an inspection at its Jadcherla facility in Telangana. USFDA inspection occurred between December 07 2016 to
09^th August 2017 USFDA Issues Form 483 to Biocon’s Bengaluru Unit Form 483 listing violations in current Good Manufacturing Plant (cGMP) have been issued by USFDA to Biocon following an inspection between May 25 and June 03 2017. USFDA noticed 10 observations in Biocon’s small molecule injectable plant in Bengaluru.....
09^th August 2017 MRA expands between Japan and EU Mutual Recognition Agreement (MRA) between Japan and EU in the area of good manufacturing process (GMP) has been amended besides working on other sections of Economic Partnership agreement. The new agreement will expand to new pharmaceutical products. Following the finalization of the MRA, the extended scope would include active pharmaceutical ingredients (APIs), biologics, vaccines and immunologicals.
09^th August 2017 Lupin Ltd Successfully Completed USFDA Inspection In an official statement, Lupin released information about USFDA inspection in its unit at Pithampur plant in Madhya Pradesh. Inspection on Good manufacturing Practices (GMP) at Unit 1 of the company’s Pithampur facility was successfully completed and it received PAI (Prior Approval Inspection) by USFDA. No observations were noted during the inspection.
09^th August 2017 CDSCO Trains New Drug Inspectors in Linewith Global Standards The Central Drug Standards Control Organization (CDSCO) has trained 100 drug inspectors and is in process of training 85 assistant drug inspectors on auditing manufacturing units for Good manufacturing Practices(GMP) across the country. India exports to around 200 countries across the globe and to ensure the quality of products, it is important to increase the inspections and audits
09^th August 2017 Equipment design as per GMP complaince GMP-compliant equipment design is gaining lot of expert’s interest as it will be more suitable for the manufacturing of medicinal products/APIs. Consequently, the only feature an equipment design should have is: system has to be qualifiable. ....
09^th August 2017 USFDA issue form 483 to INTAS Pharma’s Moraiya Biotech Unit Following a USFDA inspection, Intas Pharmaceuticals Limited’s biotech facility at Moraiya in Gujarat received quality warning. FDA issued a FORM 483 with 14 observations relating to good manufacturing practices. FORM 483 is issued to a company in case of any deviations from US Food Drug and Cosmetic (FD&C) Act and related acts. Following are observations from FDA inspectors:
08^th July 2017 New Rule for APIs from UK: Need Written Confirmation As per the Brexit: UK is now established as the ‘Third Country’ and the European Medicines Agency (EMA) and the European Commission intend to provide a series of Brexit related Questions and Answers on the consequences for the pharmaceutical industry.
08^th July 2017 FDA Warning Letter: Sampling Plans and Strategies Recently, FDA emphasized on lack of scientifically sound and appropriate sampling plans for inspection by releasing a warning letter. The warning letter underlines the lack of Company’s scientific justification for the number of reserve samples selected for the yearly visual examination.
08^th July 2017 Chinese FDA Releases Report on International Inspections Chineese “Annual Report of Drug Inspection 2016” has been published by China Food and Drug Administration (CFDA). The report summarizes the results of inspections performed by CFDA in China. Additional report gives an overview of international inspection activities.
08^th July 2017 CGMP Guidance for Medical Gases Earlier medical gases were regulated as pharmaceuticals. Considering its nature and properties, FDA has published new guidelines for the current good manufacturing practices (CGMP) for the manufacturing of medical gases. The guidelines were developed to provide
08^th July 2017 European Union frames New Action Plan on Antimicrobial Resistance as ‘One Health Vision’ Europe is considered the world’s best practice region in the field of Antimicrobial Resistance (AMR). Best practices in the world on AMR are to be found in Sweden, the Netherlands, the UK and Denmark - particularly Denmark has had great success in cutting overuse of antibiotics in farm animals - and Norway for fisheries..
08^th July 2017 ZydusCadila and NatcoPharma received marketing approval from USFDA ZydusCadila received United States of Food & Drug Administration (USFDA) approval to launch Entecavir Tablets in the two dose strengths -0.5 mg and 1 mg. The drug Entecavir is generic version which is used to treat Hepatitis B viral infection. The estimated sale as per IMS data is $166.3 million in US markets.
26^th May 2017 FDA Issued Warning Letter to Vikshara Trading and Investments Ltd FDA issued a Warning Letter and an import alert to Vikshara Trading & Investments Ltd, an Ahmadabad based manufacturing facility. During the inspection, FDA investigators were stopped from inspecting the facility. ....
26^th May 2017 Reorganization of FDA’s ORA structure Main aim of US Food and Drug Administration’s is to protect public health. To attain this FDA has to keep an update on new developments in sciences and globalization. Therefore, FDA has set up an alignment programme which helps strengthen the authority.
26^th May 2017 Markson Pharma received GMP compliance certificate from TGCA/S Marksans Pharma, a generic drug manufacturing company has received a certificate of good manufacturing practice (GMP) compliance from the Australian drugs and devices regulator for its Verna facility in Goa.
26^th May 2017 GMP Deficiency Data- A trend published by MHRA An yearly report on inspection deficiency findings has been published by the GMDP Inspectorate of the British MHRA (Medicines & Healthcare products Regulatory Agency). This time the method of data collection has been improved, thus introducing new data trending.
26^th May 2017 Biosimilar Interchangeability Guidance- An FDA Approach Since January 2017, the FDA was working on long-awaited Biosimilar Interchangeability Guidance for public. The guidance provide information on biosimilar interchangeability. Comments came from big pharmaceutical manufacturers like Pfizer, Boehringer Ingelheim.
18^th April 2017 Concept Paper for Combination Products-EMA A concept paper on ‘developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medical product’ is released by the European Medicines Agency (EMA). The concept paper advocates the need for development of a guideline on dossier requirements for medical devices that are supplied along with medicinal products....
18^th April 2017 Mutual Recognition Agreement for GMP Inspections between US and EU is finalized: Applicable to both the regions A big step towards saving time and money came into being when following a three-year-process, the United States (represented by the US FDA) and the European Union (represented by the European Commission) finally announced their agreement to mutually recognize.
18^th April 2017 New Strategic Plan for 2017-2019: Issued by PIC/S The Pharmaceutical Inspection Co-operation Scheme (PIC/S) released the new road map for the next two years. PIC/S declared that training would be imparted to its most important field of activity i.e. revised Annex 1 on Sterile Manufacturing of the PIC/S GMP Guide corresponding to the July 2016 launch of the PIC/S Inspectorates’ Academy (PIA).
18^th April 2017 Consideration should be given to API mixtures and CEP Procedure Certificate of Suitability (CEP) granted by the Certification Secretariat of the European Directorate for the Quality of Medicines (EDQM) confirms that pharmaceutical substances or active pharmaceutical ingredients (API) are produced according to.
13^th February 2017 Wockhardt Limited at Gujarat received a warning letter from US FDA along with an Import alert. US FDA issued a warning letter, dated 23 December 2016, to Indian manufacturing facility Wockhardt Limited, located at Ankleshwar, Gujarat. FDA had inspected this facility in December 2015 and issued a warning letter. The firm provided its response in January 2016, and also stated that.
13^th February 2017 Interquim, S.A., at Barcelona received US FDA warning letter. The U.S. FDA inspected drug manufacturing facility, Interquim, S.A., at Barcelona, in May 2016, and issued a warning letter, dated 22 November 2016. The summarized significant deviations from CGMP for API’s are as following.
13^th February 2017 FDA is announcing the availability of a Guidance on “Contract Manufacturing Arrangements for Drugs: Quality Agreements” US Food and Drug Administration (FDA) finalized a Guidance for industry entitled “Contract Manufacturing Arrangements for Drugs: Quality Agreements’ in November 2016. This guidance is limited to commercial manufacturing activities and describes the definition.
13^th February 2017 Changes being considered to Drugs and Cosmetic rules & GMP rules by CDSCO PE 009-13 is the PIC/S GMP Guidance which have been revised and got into force from 1st January. The revision has been successfully completed on the Harmonisation of GM(D)P by the PIC/S Sub-Committee. The Chapters of guidance which have been undergone revision are Chapter.
13^th February 2017 A Draft Guidance for "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments" was released from PIC/S. A Draft Guidance for "Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments" was released from PIC/S. "Data Governance" means the sum of all measures taken to assure data integrity. In Chapter 5 of draft guidance.
17^th November 2016 Warning letter given to Brazilian Over-The-Counter Drug Manufacturer FDA has given a warning letter to Brazil’s Mappel Industria de Embalagens on account of GMP violations related to over-the-counter drugs. The inspection was held at Sao Paulo-based manufacturing facility from 11 April to 15 April.
17^th November 2016 New agreement between EU and Japan for sharing more information on GMP inspections The European Directorate for the Quality of Medicines and Healthcare (EDQM) has announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical.
17^th November 2016 Warning given to Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA inspection The US Food and Drug Administration (FDA) has warned Japanese active pharmaceutical ingredient (API) maker Nippon Fine Chemical Co., Ltd for impeding an FDA investigator from conducting an inspection of the company's facility in Takasago City, Japan, last December.
17^th November 2016 Changes being considered to Drugs and Cosmetic rules & GMP rules by CDSCO India's central drug regulator is considering changes to the Drug and Cosmetics Rules like extending the validity of various licences and approvals in a move to improve ease of doing business for the industry. The government is planning .
17^th November 2016 EMA GMP inspection successfully completed for XBiotech (XBIT) The EMA’s Competent Authorities of France (The French Agency for the Safety of Health Products), conducted the inspection of XBiotech Inc.
17^th November 2016 US FDA has issued warning letters to three European and one Chinese drugmaker String of warning letters has been issued by US FDA at facilities run by firms in China, the UK, The Netherlands, Switzerland and China due to cGMP violations.
17^th November 2016 Warning given to Teva’s Banned Hungary Manufacturing Facility by USFDA The US Food and Drug Administration (FDA) has warned Teva’s Hungary-based manufacturing site, citing deficiencies in manufacturing operations and laboratory controls, as well as the company’s data integrity program.
17^th November 2016 cGMP Plant established in IIIM Jammu Current Good Manufacturing Practices (CGMP) Plant facility has been recently established in Jammu which would provide a high level world-class infrastructure for the manufacture of botanical.
17^th November 2016 FDA to increase vigilance over the pharmaceutical countries within Nashik District The Food and Drug Administration (FDA), Nashik has decided to keep strict vigilance on pharmaceutical companies across the district to ensure they follow all guidelines and not breach legal provisions of the Drugs and Cosmetics Act, 1940.
17^th November 2016 Warning given by France's medicines regulatory authority of fake GMP certificates According to France's medicines regulatory authority s, companies are selling active pharmaceutical ingredient (APIs) with forged documents.
17^th November 2016 Ban imposed on medicines manufactured by Maryland-based contract manufacturing organization by EMA’s CHMP The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended to ban the medicines manufactured by Maryland-based contract manufacturing organization (CMO) Pharmaceutics International
08^th October 2016 Sun Pharma working on making its plants cGMP compliant globally Sun Pharmaceutical Industries is working on making its manufacturing facilities compliant with good manufacturing practices and has asked the US health regulator to re-inspect its Halol plant as Sun Pharma has already taken detailed remediation at the Halol facility post the September 2014 inspection.
08^th October 2016 Sun Pharma working on making its plants cGMP compliant globally Sun Pharmaceutical Industries is working on making its manufacturing facilities compliant with good manufacturing practices and has asked the US health regulator to re-inspect its Halol plant as Sun Pharma has already taken detailed remediation at the Halol facility post the September 2014 inspection.
08^th October 2016 Successful inspection for Lannett’s three manufacturing facilities by USFDA The U.S. Food and Drug Administration (FDA) recently completed a cGMP inspection of the Lannett’s manufacturing facility in Philadelphia, as well as inspections of two facilities located in Armenia (Darmantest Laboratory, the company's pharmacokinetic subsidiary and Firmplace, a stability laboratory with which the company has a strategic relationship).
08^th October 2016 Ban imposed by USFDA on India’s Laxachem Organics due to GMP noncompliance The USFDA has banned products of Laxachem Organics, a maker of active pharmaceutical ingredients, from US markets as part of the effort to arrest the Burkholderia cepacia or the B Cepacia infection- a complex group of bacteria resistant to antibiotics. Laxachem issue is the first time where the US regulator has hinted.
08^th October 2016 No critical observation found as a result of UK health regulator’s GMP inspection at Wockhardt’s Aurangabad facility The UK regulator had in October 2013 withdrawn the GMP certificate to the Chikalthana plant and had also initiated recall of five prescription medicines from there. In December 2015, Wockhardt received a good manufacturing practice (GMP) certificate from the UK health regulator for its Chikalthana plant after an inspection.
08^th October 2016 Indian CDSCO plans recruitment of 500 GMP inspectors According to pharmabiz.com, the Indian Central Drug Standards Control Organization (CDSCO) is planning to recruit 500 more drug inspectors by the end of 2017. Up to now 147 inspectors have already been trained to enhance inspections of manufacturing units in line with current Good Manufacturing Practices (cGMP).
23^rd September 2016 Certification programme to tighten the quality standards in its domestic drug industry CDSCO has taken initiative to upgrade the skills of employees working in pharmaceutical and biologic manufacturing in order to bring great improvement in the quality of pharmaceutical products. The deadline set by CDSCO for completion of certification programme by all personnel in companies is 1st Jan 2018.
23^rd September 2016 Six observations issued by USFDA to Indoco’s Goa Plant on account of violation of good manufacturing norms Goa’s Indoco Remedies plant was inspected by USFDA from August 31, 2016 to September 4, 2016. On account of inspection, USFDA has issued six observations due to violation of good manufacturing norms. The injectable abbreviated new drug application (ANDA) filings triggered this inspection.
23^rd September 2016 New warning letter by FDA issued to Chinese API manufacturer Zhejiang Medicine Co. Ltd focus on data integrity The focus of FDA's Warning Letter for the Chinese API manufacturer Zhejiang Medicine Co. Ltd. dated 4th August 2016 is on the lack of data integrity. A number of alarming findings were discovered in the course of the FDA inspection in June 2015 such as deletion of original data and unavailability of records of activities at the time when they were performed.
23^rd September 2016 Regulators on strict scrutiny over drug manufacturing companies Recently Britain’s regulatory body evoked its GMP certificate for Pfizer’s Chennai Plant over quality issues and put an alert on the products made there. Between 2011 and 2016, 27 drug manufacturing plants in India received warning letters from the US Food and Drug Administration (FDA)
12^th August 2016 Warning letter issued to GlaxoSmithKline over contamination at a Penicillin Plant in UK US FDA has issued a warning letter to GlaxoSmithKline over quality control problems observed at Penicillin manufacturing facility located in Worthing in the United Kingdom. GlaxoSmithKline is therefore recalling a “small”
12^th August 2016 Warning letter issued to Chinese drug manufacturer Xiamen Origin Biotech over cGMP violations The US Food and Drug Administration (FDA) has issued a warning letter to Chinese drug manufacturer Xiamen Origin Biotech over "significant deviations" in the company's manufacturing practices for active pharmaceutical ingredients (APIs).
12^th August 2016 New draft guidance issued by FDA to help drug compounders address insanitary conditions at their facilities The US Food and Drug Administration (FDA) has issued new draft guidance intended to help drug compounders address insanitary conditions at their facilities. According to FDA, it is critical that compounding facilities avoid.
12^th August 2016 Import alert issued to Wockhardt by USFDA The US Food and Drugs Administration (FDA) issued an import alert on Wockhardt’s Ankleshwar plant on account of GMP violations. The US FDA had carried out an inspection at the Ankleshwar plant in November last year and issued adverse observations known as Form 483 for violating good manufacturing practices.
12^th August 2016 Pfizer under list of drugmakers for deviating from Good Manufacturing Practices In the last week of June, a high profile team drawn from world's four leading regulators identified a number of deficiencies related with GMP violations at Pfizer’s Irungattukottai facility, near Chennai. The team included UK's Medicines and Healthcare products Regulatory Agency (MHRA), US FDA, Therapeutic Goods.
12^th August 2016 GMP non-compliance observed by MHRA at two US sites for Pharmaceutics International Inc The Medicines and Health Care products Regulatory Agency (MHRA) has observed critical deficiencies at US based contract manufacturing organization Pharmaceutics International, Inc. for two of its Maryland facilities
05^th July 2016 GMP non-compliance observed by MHRA at two US sites for Pharmaceutics International Inc The Medicines and Health Care products Regulatory Agency (MHRA) has observed critical deficiencies at US based contract manufacturing organization Pharmaceutics International, Inc. for two of its Maryland facilities
05^th July 2016 Agreement signed between Export Inspection Council of India and the US health regulator to facilitate sharing of information relating to import alerts Export Inspection Council of India (EIC) and the US health regulator have signed an agreement in order to facilitate the sharing of information with respect to import alerts.
05^th July 2016 Warning Letter issued to BBT Biotech, Germany by USFDA on account of Data Integrity Issues The USFDA has issued a warning letter to BBT Biotech; Germany on account of GMP violations. The company needs to respond to the letter with measures taken to remedify the deviations / violations within 15 working days of receipt of the letter.
05^th July 2016 Non-compliance report with respect to GDP issued in EudraGMDP by Czech Republic The competent authority of the Czech Republic issued three GDP non-compliance reports to three companies which were entered into the community database for GMP and GDP compliance. While GMP Non-Compliance Reports are entered frequently, reports about GDP compliance issues are not published very often.
05^th July 2016 Warning letter issued to S.R. Burzynski Manufacturing Facility, Texas on account of cGMP violations The U.S. Food and Drug Administration (FDA) inspected the clinical supply manufacturing facility, S.R. Burzynski Manufacturing Facility at 12707 Trinity St., Stafford, Texas and issued warning letter which summarizes significant.
28^th June 2016 ISO Warning letter issued to Mumbai based Megafine Pharma by USFDA Mumbai based Megafine Pharma has received a warning letter from USFDA on account of violations of Good Manufacturing Practices. Summarizing the violations from cGMP (current good manufacturing practice) norms at the Nasik facility
28^th June 2016 Imports banned from Teva’s Hungary Plant by FDA except for two drugs in shortage The US FDA has announced an import alert prohibiting drugs made at the Godollo, Hungary-based manufacturing site from entering the US.
28^th June 2016 Domestic Pharma Manufacturing Site Inspections significantly decline for CFDA According to a recently released annual report from the Center for Food and Drug Inspection of CFDA (China’s Food and Drug Administration), CFDA inspected.
28^th June 2016 Roadmap designed to chart the path to large-scale manufacturing of cell-based therapeutics A national roadmap has been designed by an industry driven consortium to chart the path to large-scale manufacturing of cell-based therapeutics for use.
28^th June 2016 The API manufacturers in India remain in the limelight of European GMP Inspectors According to The EudraGMDP database, Indian API manufacturers are having more frequent non-compliance reports as observed in three of the reports
28^th June 2016 WHO released final guidance document on Good Data and Record Management Practices WHO has released the final version of the Good Data and Record Management Practices. In the guidance document "good documentation practices" has now been
06^th June 2016 ISO 22716 Cosmetics GMP awarded to Bollore Logistics The ISO 22716 cosmetic GMP introduces a management systems’ approach to documenting and regulating the production, control, storage and shipment of cosmetics products.
06^th June 2016 Draft Supplementary guidelines on GMP HVAC systems released by WHO The WHO has released supplementary guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms. During the consultation on data management, bioequivalence.
06^th June 2016 Draftguidance released by FDA concerning additive manufacturing technologies for 3D printed medical devices The U.S. Food and Drug Administration (FDA) has issued draft guidance for additive manufactured medical devices.
06^th June 2016 Pharma manufacturers to be trained in good manufacturing practices after USFDA concerns by CDSCO Currently there are no common regulations in India for the pharma manufacturing practices as a result of which the USFDA has constantly issued warning.
06^th June 2016 New draft guideline on the sterilization with regards to the manufacturing of Medicinal Products, APIs, Excipients and Primary Containers released by EMA EMA has released a new draft guideline entitled "Guideline on the sterilization of the medicinal product, active substance, excipient and primary container
06^th June 2016 New policy with respect to grouping of supplements for chemistry, manufacturing and controls (CMC) changes released by FDA The US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) has released a new document with respect to grouping of supplements and their submission concurrently for the same chemistry.
06^th June 2016 Critical cGMP Global Operations Center for Genzyme Corporation, a Sanofi Company has been acquired by Capri EGM Capri EGM is an investment company specializing in corporate sale leaseback and build-to-suit financing, and the acquisition of institutional quality single-tenant office.
06^th May 2016 Warning given to Sri Krishna Pharmaceuticals by FDA on serious quality control violations Sri Krishna Pharmaceuticals Limited (SKPL) is the pioneer in the manufacture of ACETAMINOPHEN (PARACETAMOL) for the domestic market and is today.
06^th May 2016 Steps Taken for setting up of cGMP facility for yellow fever drugs by the government of India To ensure that Indian vaccine manufacturers have global quality standards, the government is exploring the feasibility of establishing WHO.
06^th May 2016 Two Indian APIs removed from Pre-qualification list by WHO for GMP non-compliance Pyrazinamide and Sulfadoxine, two APIs of the Indian pharma manufacturer Anuh Pharma Ltd has been removed from the WHO list of pre-qualified APIs by the World Health Organization.The step has been taken as a result of an inspection.
06^th May 2016 Guidance on process validation with respect to good manufacturing practice finalized by EMA Process validation is defined in International Conference for Harmonization's (ICH) Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients as, "The documented evidence that the process, operated within establish parameters.
06^th May 2016 Good Manufacturing Practices to be adopted by Vaidyakhana Bikas Samiti, Nepal based herbal medicine producer After receiving the approval to build a GMP certified production house under WHO guidelines, which include upgrading its production equipment, lab and building, Venerable herbal medicine producer Singha Durbar Vaidyakhana Bikas Samiti.
25^th April 2016 FDA offers new draft guidance on Data Integrity in cGMP Drug Manufacturing US FDA has released new draft guidance on data integrity in cGMPmanufacturing due to recent concerns over data.
25^th April 2016 Non-compliant Chinese manufacturers continue to be under FDA scanner US FDA has issued import alert to three more Chinese Pharmaceutical companies for failing to meet the good manufacturing practice (GMP) standards of FDA and for refusing an FDA inspection. According to FDA.
25^th April 2016 Shut down of 16 Herbal Medicine Facilities at Nigeria by NAFDAC (The National Agency for Food and Drug Administration and Control) The National Agency for Food and Drug Administration and Control (NAFDAC) had shut 16 herbal medicine facilities and seized products over illegal operations in Onitsha, Anambra. The raid was done for the illegal.
25^th April 2016 Non-compliance report issued to Marksans Pharma Limited on account of GMP violations by MHRA The British authority MHRA (Medicines & Healthcare products Regulatory Agency)had published a Non Compliance Report against the Indian company Marksans Pharma Limited on account of data integrity issues.
25^th April 2016 GMP certificate given to Shilpa Medicare for two of its API sites from Japan Regulator (PMDA-Pharmaceuticals and Medical Devices Agency) Shilpa Medicare Ltd is an API manufacturer based in Raichur, Karnataka, India. Currently the company is one of the leaders in the Oncology market and offer a complete range of products in this segment spanning across APIs.
11^th March 2016 Training Modules on "ICH Q3D - Elemental Impurities" published by ICH The ICH has published the long-announced training modules on the ICH Q3D Guideline "Elemental Impurities".
11^th March 2016 Warning letter issued to a Manufacturer of Medicinal Products in Hong Kong by FDA The FDA issued a warning letter to a manufacturer of medicinal products in Hong Kong on 15 December 2015. The FDA investigator identified.
11^th March 2016 India and EU working together to sort out regulatory issues with respect to GMP India and EU are engaged together to sort out regulatory issues between the two countries and expand and strengthen technical co-operation on good manufacturing practices on account of 28-nation block's.
11^th March 2016 Major GMP violations at API manufacturers in India and China Two Non-Compliance reports were issued at the end of last year at API production sites in China and India. GMP inspectors from the French competent authority found 2 critical.
11^th March 2016 Falsification and GMP Non-compliance again observed with Chinese Heparin Manufacturer In 2008 adulterated Heparin from China caused the death of 81 people and 785 reports of serious injuries.A comprehensive investigation of the US congress identified weaknesses in the GMP Inspection
08^th February 2016 Yearly List of New and revised draft guidances published by The U.S. Food and Drug Administration (FDA) The yearly list of new and revised draft guidances had been published by The U.S. Food and Drug Administration (FDA). A total of 102 planned guidance documents have been.
08^th February 2016 Revised guideline named “ WHO GMP for Biological Products”listed by WHO The WHO has listed a revised guideline WHO GMP for Biological Products which is a 38-pages guideline and applies to the manufacture, control and testing of biological products for human use, from starting materials and preparations.
08^th February 2016 Dr. Reddy’s Laboratories to resolve issues raised by USFDA regarding cGMP norm violations Dr. Reddy’s Laboratories had received a warning letter on November 5, 2015 from the USFDA regarding deviations from current good manufacturing practices (CGMP) at its active pharmaceutical ingredient (API) facilities at Srikakulam.
08^th February 2016 13334 Indian Products and 15087 Chinese products rejected by USFDA in past 6 years on account of GMP violations According to the FDA data, 13,334 products made in India and imports of 15,087 Chinese products were rejected by the US Food and Drug Administration.
08^th February 2016 COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 published by the European Union on 9th February 2016 On 9th February 2016 the European Union has published the "COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament.
15^th January 2016 Yearly List of New and revised draft guidances published by The U.S. Food and Drug Administration (FDA) The yearly list of new and revised draft guidances had been published by The U.S. Food and Drug Administration (FDA). A total of 102 planned guidance documents have been
15^th January 2016 Revised guideline named “ WHO GMP for Biological Products”listed by WHO The WHO has listed a revised guideline WHO GMP for Biological Products which is a 38-pages guideline and applies to the manufacture, control and testing of biological products for human use, from starting materials and preparations.
15^th January 2016 Dr. Reddy’s Laboratories to resolve issues raised by USFDA regarding cGMP norm violations Dr. Reddy’s Laboratories had received a warning letter on November 5, 2015 from the USFDA regarding deviations from current good manufacturing practices (CGMP) at its active pharmaceutical ingredient (API) facilities at Srikakulam.
15^th January 2016 13334 Indian Products and 15087 Chinese products rejected by USFDA in past 6 years on account of GMP violations According to the FDA data, 13,334 products made in India and imports of 15,087 Chinese products were rejected by the US Food and Drug Administration.
15^th January 2016 COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 published by the European Union on 9th February 2016 On 9th February 2016 the European Union has published the "COMMISSION DELEGATED REGULATION (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and.
10^th December 2015 Wockhardt's Chikalthana Plant Clears GMP Certificate from UK Health Regulator MHRA and Climbs in Share Price Wockhardt’s Chikalthana plant at Aurangabad in Maharashtra has received a good manufacturing practice (GMP) certificate from the UK health regulator (MHRA) as post- inspection result..
10^th December 2015 Anuh Pharma Receives GMP Certificate for Anti-Bacterial Drug; Blows Up 2.4% Anuh Pharma is one of the leading manufacturers of Active Pharmaceutical Ingredients (API's). Registered in 1960, the company has grown several folds and ..
10^th December 2015 US FDA Wants Third-Party Audit for GMP and Compliance of Dr Reddy's Units The US Food and Drug Administration (FDA) inspected three main Indian facilities of Dr.Reddy’s Laboratory and issued warning letters for facility.
10^th December 2015 Exporters Stipulate to Enhance Validity of WHO GMP Certificate from 2 To 3 Years The pharmaceutical exporters have demanded to enhance the validity period of World Health Organization - Good Manufacturing Practices (WHO GMP) ..
10^th December 2015 GMP Challenges for Advanced Therapy Medicinal Products Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of Advanced Therapy Medicinal Products (ATMPs) in the EU is proving to be a complex task.
10^th December 2015 USFDA Issues Warning Letter for Three Indian Facilities of Dr. Reddy’s Laboratory USFDA has made charges against DRL for significant deviations from current Good Manufacturing Practices for manufacture of APIs at two facilities and violations of CGMP.
10^th December 2015 4Life Starts New Manufacturing Facility in Vineyard, Utah 4Life General Managers from around the world gathered for a ribbon-cutting at the new 4Life manufacturing facility in Vineyard, Utah. The facility will
26^th November 2015 The European Commission publishes the final version of the revised EU-GMP Guideline Annex 16 Certification by a Qualified Person and Batch Release The European Commission has published the final version of the revised EU-GMP Guideline. The guideline specified in Annex 16, under the title..
26^th November 2015 FDA Bans Imports from Major Indian API Manufacturer Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, is now added to the list of foreign manufacturing sites.
26^th November 2015 Novartis gets USFDA warning letter for two plants in India Indian active pharmaceutical ingredient (API) manufacturer Megafine Pharma's Nashik site in Maharashtra, India, is now added to the list of foreign manufacturing sites ..
26^th November 2015 UK™s MHRA Calls out GSK China Plant over GMP Non-Compliance The UK™s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released an inspection report that found a GlaxoSmithKline (GSK)
26^th November 2015 DCC invites suggestions for amendment of Schedule M of Drug & Cosmetic (D&C) Rules The Drug Consultative Committee (DCC) has proposed the amendment of Schedule M of Drugs & Cosmetics Rules (D&C Rules), 1945 to harmonize the provision with WHO.
26^th November 2015 Cartiva announces GMP Certification by Brazilâ€™s regulatory agency ANVISA Cartiva, Inc. announced that it has received GMP (Good Manufacturing Practices) certification from Brazil's National Health Surveillance Agency (known as ANVISA).
26^th November 2015 USFDA warns Unimark over violating GMP norms The US Food and Drug Administration (USFDA) has issued a warning letter to Unimark Remedies for violating current good manufacturing practice norms at its plant near Ahmedabad in Gujarat.
26^th November 2015 China Food and Drug Administration (CFDA) issues four guidelines for Medical Device Good Manufacturing Practice on-site inspection China Food and drug Administration has issued various important guidelines to promote the implementation of the Good Manufacturing Practice for Medical Devices
26^th November 2015 Novartis gets FDA approval for skin cancer drug combination Novartis AG announced on Friday that the US Food and Drug Administration (FDA) has provided a regular approval for its new drug combination for treatment.
07^th October 2015 PAN Drugs receives warning letter from USFDA USFDA has recently issued a warning letter to PAN drugs Vadodara based plant due to significant deviations from good manufacturing practices.
07^th October 2015 MHRA issues recall notice of Lacri-Lube eye ointment The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a recall notice to Allergen Limited. The recall notice relates to 5g and 3.5g pack sizes of
07^th October 2015 Another Import Ban for Polydrug Laboratories USFDA (Food and Drug Administration) issues import ban for products manufactured by Polydrug Laboratories. It was issued on Sept. 11, 2015 for
07^th October 2015 Health Canada lifts its ban from two Apotex facilities in India Health Canada has lifted its ban from Apotex two Indian facilities. Canadaï¿½s drug regulator reinspected the two plants in June and determined
07^th October 2015 33 drugs were found to be of not of standard quality during Surprise inspection Recently Karnataka drug control department had conducted surprise inspections to pick up drug samples at random. The drug test labs have issued their result.
07^th October 2015 Vivimed Labs successfully completes USFDA inspection of its manufacturing facility Vivimed Labs has recently successfully completed inspection of its API manufacturing facility in Spain. After the completion of inspection Vivimed said ï¿½the USFDA inspectors concluded
14^th September 2015 Pharmaceuticals Export Promotion Council of India (Pharmexcil) updates its database The Pharmaceuticals Export Promotion Council of India (Pharmexcil) has recently updated and added regulatory data for Ayush products of five more countries to its
14^th September 2015 USFDA issues warning letter to Mylan for lapses in three units at Karnataka USFDA has issued a warning letter to Mylan Laboratories for its three plants in Karnataka. The US Food & Drug Administration (USFDA) issued the letter due.
14^th September 2015 Health Ministry of India soon to amend Schedule K for providing exemption from GMP compliance for export The Union health ministry will soon amend Schedule K of the Drugs and Cosmetics Rules, 1945. The amendment will make a provision under the Drugs and Cosmetics
Anvisa approves Caplin point Chennai located sterile injectable site Anvisa, Brazilian regulatory authority has recently approved Caplin point sterile injectable manufacturing site at Chennai. After approval from Brazil's National Health Surveillance
US Food and Drug Administration issues warning letter to Cepheid's Swedish site The US Food and Drug Administration has issued a warning letter to Cepheid's European manufacturing and R&D site in Solna, Sweden
Dr. Reddy's voluntarily recalls Rivastigmine Tartrate Capsules from US market Dr. Reddy™s has recently voluntary recalled Rivastigmine Tartrate Capsules of 1.5 mg strength from the USA market, following
French National Agency for Medicines and Health Products Safety (ANSM) releases TxCell manufacturing facility inspection report The French National Agency for Medicines and Health Products Safety (ANSM) has released the Tx cell manufacturing inspection report.
3^rd August 2015 MHRA develops a new blog on GMP Data integrity MHRA has recently developed a new blog on GMP Data integrity in addition to the existing data integrity guideline by the MHRA.
EMA issues draft guideline on manufacture of the finished dosage form EMA has recently issued draft guideline on manufacture of the finished dosage form. This guideline replaces
FDA issues Guidance for Industry on "Allowable Excess Volume and Labelled Vial Fill Size in Injectable Drug and Biological Products" USFDA recently issues its final guidance for industry on Allowable Excess Volume and labelled Vial Fill Size in Injectable Drug and Biological Products
USFDA orders for recalls of drug products from three pharmaceutical firms US Food and Drug Administration (FDA) has ordered the recall of all drug products from Allied Pharmaceutical Laboratories Inc.
"USFDA issues Form 483 to Lupin’s Goa Plant" The US Food and Drug Administration (USFDA) has issued Form 483 to Lupin & trades Goa plant. The Goa plant supplies drugs (oral solids and formulation) to markets
US FDA issues warning letter to Mahendra Chemicals, Gujarat U.S. Food and Drug Administration (FDA) has issued warning letter to Mahendra Chemicals manufacturing facility, Gujarat, India.
EMA announces conduction of review of Medtronicâ€™s product, InductOs The European Medicines Agency (EMA) has announced it is conducting a review of Medtronic's implantable bone-development product, InductOs.
Caplin Point gets European Union (EU GMP) approval for its Chennai located Sterile Injectable Site Caplin Point has received European Union (EU GMP) approval for its small volume sterile injectable liquids facility at Chennai. Commenting on
10^th July 2015 European Medicinal Agency soon to issue New GMP annex for importers of medicinal products The European Medicinal Agency (EMA) will soon release a new GMP annex to EU GMP Guidelines. EMA has released its concept paper on new guidance for importers of medicinal products
USFDA issues CMC (Chemistry, Manufacturing and Control) reportable changes draft guidance The US FDA (Food and Drug Administration) has issued draft guidance on the established conditions: Reportable Chemistry,
Pharmacopeial Forum 41(1) publishes a new article on pharmaceutical packaging Pharmacopeial Forum 41(1) publishes a new article â€œstimulus to the revision process" on pharmaceutical packaging. The article will be published as General Chapter
Wockhardt again recalls captopril tablets from market along with clarithromycin tablets Wochardt has recently recalled 166 bottles of captopril tablets of 50 mg strength along with 50 bottles of clarithromycin tablets of 500
Mylan expanding its nationwide recall in US to hospital/user level Mylan has announced that its U.S.-based Mylan Institutional business is expanding its voluntary nationwide recall to the hospital/user level
USFDA issues warning letter to Insulet Corp USFDA (Food and Drug Administration) has issued Insulet Corp Form 483 over some insulin pumps. Insulet official said "The letter relates to
Polydrug API Plant found to have 17 breaches of cGMP requirements at its Maharashtra plant The agency for medicinal products and medical devices of the Republic of Solvenia (Jazmp) conducted inspection of Polydrug API India based Plant
AmpliPhi Biosciences announces grant of cGMP Certification for its Bacteriophage Facility AmpliPhi Biosciences on 3rd May, 2015 has announced that it has received good manufacturing practices certification for its bacteriophage facility in
1^st June 2015 USFDA issues Form 483 to Impax Laboratories Hayward, California manufacturing facility USFDA has issued Impax laboratories form 483 Hayward facility. Impax on 11th May, 2015 announced that FDA performed a three week inspection
Nectar Lifesciences Limited (NecLife) receives ANVISA approval for its Cephalosporin API's manufacturing facility Nectar Lifesciences Limited (NecLife) has received ANVISA cGMP ("Current Good Manufacturing Practices") approval for its Cephalosporin API's manufacturing facility. The National Health Surveillance Agency
Therlase manufactures high purity anti cancer drug meeting GMP standards Theralase technologies inc. has successfully manufactured GMP grade lead, light activated, anti cancer drug, TLD-1433, specifically developed for the treatment of cancer. This latest high purity batch will be used
Wockhardt's voluntarily recalls captopril tablet from market Wockhardt has initiated recall of 93,393 bottles of blood pressure drug captopril tablets in the US market due to failing to meet specifications. It is a Class II recall. A class II
USFDA issues warning letter to two sterile compounders US FDA has recently issued warning letter to Florida based absolute pharmacy and Van Healthcare Services. Florida based Absolute Pharmacy
6^th May 2015 Health Canada recently launches GMP inspection database Health Canada has recently launched a GMP inspection database. This database contains 3,821 inspections (per March 2015) which
Health Ministry planning over India being member country to Pharmaceutical Inspection Convention (PIC) PIC/SÂ Union Health Ministry is seriously planning over making India a member country to Pharmaceutical Inspection Co-operation Scheme (PIC/S) initiative
Eurpoean Medicine Agency (EMA) publishes guideline "Elemental impurities in marketed products. Recommendations for implementation" On 27 March 2015, Eurpoean Medicine Agency (EMA) has published guideline "Elemental impurities in marketed products. Recommendations for implementation"
Wockhardt voluntarily recalls 12 drugs manufactured in its two Indian facilities, Chikalthana and Waluj from US market Wockhardt on 29 April, 2015 has decided to voluntarily recall its products manufactured in its two Indian facilities, Chikalthana and Waluj facilities from US market
USFDA issues warning letter to Natus Medical Incorporated USFDA has issued warning letter to Seattle located Natus Medical Incorporated firm on 10th April, 2015. Natus Medical Incorporated manufactures
FDA warns for use and ceases distribution of supplements containing DMBA (1, 3 -Dimethylbutylamine) FDA has recently demanded that 14 companies in the natural products industry cease distribution of supplements that contain a substance known a
European Union (EU) publishes its final revised EurdraLex Volume 4, Annex 15 guideline European Union has published its revised EurdraLex Volume 4, Annex 15: Qualification and Validation guidelines. This document is a GMP
MHRA publishes revised Pre-Inspection report and Interim Compliance report guidance Â MHRA has published its revised guidance for Pre-Inspection report and Interim Compliance report in March 2015. In revised documents a section on
USFDA issues import alert to IPCA labsâ€™ two manufacturing sites IPCA Labs has received US Food and Drug Administration (FDA) import alert for two of its Active Pharmaceutical Ingredient (API) manufacturing units
USFDA has issued warning letter to Hospiraâ€™s Italian facility Hospira has received warning letter from USFDA for its Italy based plant on 31st March, 2015. Hospira makes biosimilars and a generic
USFDA issues Form 483 to Galena Biopharma (GALE) USFDA has issued warning letter to galena Biopharma on April 6, 2015. During inspection to Galena Pharma Portland, Oregon facility the U.S.
FDA warns for the use of product from Prescription Center Pharmacy in Fayetteville, North Carolina FDA has warned health care professionals and patients not to use products from the Prescription Center Pharmacy in Fayetteville, N.C. due
Eurogetac has successfully manufactured 150 grams of GMP grade plasmid DNA Eurogentec SA, a contract manufacturing organization has successfully manufactured 150 grams of GMP grade plasmid DNA.
30^th March 2015 FDA has published final draft guidance for industry on mixing, diluting, or repackaging biological products outside the scope of an approved Biologics License Application (BLA) FDA in February has published new draft guidance for industry on Mixing, Diluting, or Repackaging Biological Products outside the scope of an approved Biologics License Application,
USFDA issues its final guidance on medical devices reprocessing: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" USFDA has finally issued its final guidance on reprocessing of medical devices on March 12, 2015. The draft guidance was released in 2011
India Health Ministry planning for amending Schedule MIII To improve the quality of manufactured medical devices Health Ministry of India has proposed amendment to Schedule MIII
National Science Foundation (NSF) has published 1st American Standard on GMP for pharmaceutical excipients The National Science Foundation (NSF), a United States government agency has published first American standard on GMP for
PIC/S (Pharmaceutical Inspection Co-operation Scheme) publishes its two revised GMP guidance documents On Jan 2014, PIC/S (Pharmaceutical Inspection Co-operation Scheme) published two revised GMP annex guidance document namely
Indian Pharma Companies needs external support to resolve Data Integrity Issues: USFDA During the year 2014, USFDA issued warning letters to Indian pharmaceutical companies on data integrity issues.
European Medicinal Agency publishes its Works Plan for GMP/GDP Inspectors Working Group for 2015 European Medicinal Agency published its Works Plan for GMP/GDP Inspectors Working Group for 2015.
Sun Pharma voluntarily recalls Ketoroloc Tromethamine eye drop in US for failing to meet specifications Sun Pharma is voluntarily recalling over 5000 bottles of Ketorolac Tromethamine ophthalmic solution in the US market for failing
Hospira voluntarily recalled sodium chloride and magnesium sulfate injections due to contamination and labeling error respectively Heritage and Sagent Pharmaceuticals recalled their products due to sterility concerns
Heritage and Sagent Pharmaceuticals recalled their products due to sterility concerns Sagent and Heritage pharmaceuticals are voluntarily recalling their products following FDA observations of practices
26^th February 2015 FDA released draft guidance for cGMP requirements for Combination Products FDA Released Draft Guidance for cGMP requirements for Combination Products codified as 21 CFR part 4. These draft guidance, when finalized,
European Medicinal Agency (EMA) released concept paper on revision of GMP guidelines for sterile product manufacturers EMA prepared a draft concept paper for revision of Annex 1 which gives GMP guideline for the manufacturers of sterile
A new USP Chapter on â€œVisual Inspection of Injections published for comments A new chapter no. 1790 which is regarding the 100% visual control of injectables is issued as a first draft
MHRA new guidance for industry on GMP data integrity definitions MHRA announced its guidance for industry on GMP data integrity definitions on January, 2015. Data integrity requirements
European Union (EU) issues its revised GMP guidance™s for Production and "Premises and Equipment" Production and "Premises and Equipment" are chapter 3 and Chapter 5 of good manufacturing practice (GMP) guidance's
Global Recall of multiple Lots of Ketorolac Tromethamine injection due to potential particulate in glass vials Global Recall of multiple Lots of Ketorolac Tromethamine injection distributed from February 2013 to December 2014 in the United States
FDA issues warning Letter to Verichem Laboratories FDA has issued warning letter to Verichem Laboratories for manufacturing adulterated medical devices on February 4
Health Canada issues notice regarding regulation for commercially reprocessed single-use medical devices Health Canada has issued notice for the companies that reprocess and distribute medical devices originally authorized
Iran attempting to adopt GMP guidelines for radiopharmaceuticals Iran is currently attempting to acquire the good manufacturing practice (GMP) standards for radiopharmaceuticals.
Cynata will soon move to manufacture world first GMP-grade mesenchymal stem cells (MSCs) Cynata Therapeutics (formally EcoQuest) is an Australian stem cell and regenerative medicine company that is developing
PLIVA Successfully completes FDA Inspection PLIVA has successfully completed site inspection done by FDA on February, 2015. PLIVAâ€™s Production process is regularly
VEXIM successfully completes GMP Inspection by Brazil's National Health Surveillance Agency (ANVISA) Vexim is a medical device company created in February 2006. Recently Brazil's National Health Surveillance Agency
30^th January 2015 Planning of GMP Inspections by FDAâ€™s New Quality Metrics Programme A comprehensive new organization has been initiated by the US Food and Drug Administration(USFDA) for its inspection activities.
GMP Approved Facility for Tianyin Pharmaceutical granted by China China Food and Drug Administration (CFDA) has provided Good Manufacturing Practice (GMP) certificate to
USFDA Poses Import Alert on Ratlam Plant of Ipca Labs for Violations of Production Practices Ipca Laboratories have announced on Friday that it had received an import ban for its active pharmaceutical ingredients
Suspension called for Generic Forms of Four Common Psychiatric Drugs by the European Medicines Agency After observations were made about the use corrupt practices in the regulatory approval processes for the drugssuspension of
Gabapentin Capsules recalled by Aurobindo and Actavis Following complaints of empty capsules in the US market, drug firm Aurobindo Pharma is recalling 24,816 bottles of Gabapentin devices
Action Plan Prepared by Apotex Apotex Pharmachem is the largest manufacturer, researcher and developer of active pharmaceutical ingredients in Canada
15^th January 2015 Launch Of Project to take care of quality control lapses at drug manufacturing sites by US FDA US FDA took an initiative for reducing quality control issues at pharmaceutical manufacturing sites. At a news conference Dr. Janet Woodcock
Withdrawal of GMP certification from Indian manufacturer by Italian Medicines Agency Italian Medicines Agency has issued a warning letter to the Hyderabad based Sri Krishna Pharmaceuticals due to GMP deviations
Detention of Drugs from Sri Krishna Pharma by Health Canada Health Canada requested the Canadian importers to detain health products which use raw materials from the API manufacturer, Sri Krishna
Restrictions on Wockhardt Plant eased by UK regulator The UK MHRA has carried out an audit of the Wockhardt's drug unit at Chikalthana, near Aurangabad in order to understand
Warning given to Chinese active pharmaceutical ingredients (API) manufacturer by USFDA-Indian Drug Manufacturers may be impacted Chinese manufacturer Novacyl Wuxi Pharmaceutical has been given warning over basic manufacturing problems at its facility
New Medical Device GMP and GSP rules introduced by China China's Food and Drug Administration ("CFDA") revised the existing provisional Good Manufacturing Practices for medical devices
USFDA import alert lifted from Costa Rica facility of Hospira Hospira's Costa Rica facility received a warning letter from the agency in August 2012 as the devices manufactured at this site did not comply