Institute of Good Manufacturing Practices India

(An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India)

Pharma GMP Newsletter


Warning Letter issued to Chinese OTC Manufacturer: Violations of Current Good Manufacturing Practice (CGMP) regulations

On March 26, 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese manufacturer operating a U.S.-registered facility, known for produci


Inadequate Equipment and Facility Design

The FDA issued a Warning Letter to Amman Pharmaceutical Industries, a Jordanian manufacturer, after finding significant violations during an August 2023 inspection. The


Indian Sterile Facility in a Dilapidated Condition

In October 2022, Madhu Instruments Private Limited in India received a Warning Letter from the FDA due to unsanitary conditions discovered during an inspection. Issues


FDA issued a warning letter for reprocessed medical devices: Renovo

Renovo specializes in reprocessing and cleaning medical devices like Depuy Mitek Ablation Wands and Ethicon Bladeless Trocars. While holding multiple 510(k) c


EU Non-Compliance Report issued after insufficient CAPA

A recent EU Non-Compliance Report issued by the Maltese Medicines Authority to Cubit Lifesciences in India highlights significant observations, necessitating a detailed


FDA Warning Letter to Drug Manufacturing Facility in Thailand

The U.S. Food and Drug Administration (FDA) issued a Warning Letter on February 27, 2024, to a drug manufacturing facility in Thailand for serious violations of Current


FDA sends three warning letters in probe of plastic syringes made in China

In late 2023, the FDA commenced evaluating plastic syringes from China for quality issues, advising against their use due to reported problems. Warning letters were issued to Medline Industries and


EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications

The FDA and the European Medicines Agency (EMA) have jointly published "EMA–FDA joint Q&As on Quality and GMP aspects," aiming to support quality enhancement


Exactech drilled with a warning letter over implant packaging

The FDA issued a warning letter to Exactech regarding packaging issues with its orthopaedic implants, potentially hastening device degradation. Exactech, a manufacturer


FDA warning letter over issues at ex-Ivenix site: Fresenius Kabi

Fresenius Kabi received a warning letter related to large-volume infusion pumps acquired through its $240 million takeover of Ivenix. The FDA cited delays in completing


FDA Warning Letter on unapproved and misbranded Drugs

On February 7, 2024, the FDA issued a Warning Letter to a company based in the United States, US Chem Labs. The letter addresses the marketing and distribution of


Non-compliance Report (EudraGMDP): Cross-Contamination Risk at Indian Pharmaceutical Company

Following an inspection of Saga Lifesciences Limited, an Indian pharmaceutical manufacturer, the Maltese authority issued a non-compliance report. This inspection serve


Telangana and Goa regulators qualified to observe US FDA inspections in India

The US Food and Drug Administration (FDA) announced that Goa and Telangana's regulatory bodies can now observe inspections conducted by the FDA in India. These states j


Parliamentary Panel advises revision of MAI, PLI strategies to boost pharma exports

The Commerce Parliamentary Standing Committee proposed revisions to the Market Access Initiative (MAI) guidelines to support large enterprises and recommended adjusting


KMIO framing complete state childhood cancer policy to place it as a national guideline

The Kidwai Memorial Institute of Oncology (KMIO) in Karnataka is crafting a comprehensive childhood cancer policy for the state, aspiring to set a national standard for


CDSCO issues regulatory policies for sampling of drugs, cosmetics and medical devices

The Central Drugs Standard Control Organisation (CDSCO) has issued final regulatory guidelines to streamline sampling procedures and maintain a centralized database. Th


A new FDA Warning Letter for Chinese Company after the Review of Records

We recently covered a Warning Letter issued to a Chinese manufacturer for significant breaches of cGMP regulations concerning finished pharmaceuticals. The U.S. Food an


FDA Warning Letter states about observation of particulates in repackaged drug components

In January 2024, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Glicerinas Industriales, S.A. de C.V., a Mexican company, following a May 2023 i


WHO: Updated Edition of the GMP Compendium for Medical Products

The World Health Organization (WHO) has published the 10th edition of the "Quality Assurance of Pharmaceuticals: a Compendium of Guidelines and Related Materials, Volum


ICMR issues extensive guidance on ethical prerequisites for laboratory validation testing

The Indian Council of Medical Research (ICMR) has recently issued detailed guidelines titled "Ethical Requirements for Laboratory Validation Testing" to uphold ethical


FDA Revision to the Guidelines on Quality Considerations for Ophthalmic Drug Products

FDA has updated its guidance on Quality Considerations for Ophthalmic Drug Products in response to recent incidents of microbial contamination and safety recalls. The r


New FDA Warning Letter for inadequate Quality Oversight

The FDA issued a Warning Letter to a pharmaceutical company in Thailand for breaching current Good Manufacturing Practice (CGMP) regulations. The letter cited numerous


India's Health Ministry modifies GMP Rules - and replaces the 'GMP' Term.

The Indian pharmaceutical industry, a major exporter of generic drugs, faces scrutiny for occasional lapses in quality. In response, the Ministry of Health has issued r