About FCRDS

Faculty of Clinical Research and Drug Safety (FCRDS) has been set up under the aegis of ‘Institute of Good Manufacturing Practices India'. Institute of Good Manufacturing Practices India, registered as a non-profit society ( under The Societies Registration Act,1860) with Government of India recognised by the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India, accredited Vocational Institution of Ministry of Education, Government of India, approved training Institute of Food Safety and Standards Authority of India (FSSAI) and affiliated with Life Sciences Sector Skills Council (SSC) and Food Industry Sector Skills Council of National Skill Development Corporation (NSDC) -presents unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing. GMP in itself is the most dynamic part which witnesses frequent changes in terms of newer rules being added and older ones being renewed. Keeping self updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs and practices.

About IGMPI

The Institute of Good Manufacturing Practices India, registered under SR Act XXI of 1860, Government of India, recognised by Ministry of Commerce & Industry, accredited Vocational Institution of Ministry of Education, Government of India and approved by Food Safety and Standards Authority of India (FSSAI) presents a unique, friendly and interactive platform to get rid of all your GMP compliance related issues. GMP- an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing and sustainability services - in itself is the most dynamic part which witnesses frequent changes in terms of new rules being added and old ones being renewed. Thus, keeping oneself updated with current GMPs is essential to remain aligned with evolving industry requirement and standards.

Our team comprises knowledgeable professionals from diverse sectors such as Pharma, Healthcare, Food & Nutraceutical industries, pooling together their expertise, know-how, and practical experiences to create this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as a stronger and better education and training platform provider for professionals and students in the areas of GMP, Quality Assurance and Control, Pharma, Food & Nutrition and Healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. Our board of governors and specialists have collated their acumen and are offering state-of-the-art courses which includes GMP training, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR, Environment Social Governance (ESG), and Good Laboratory Practice in form of formal classroom studies, online/interactive programmes, online seminars, as well as onsite training programmes along with the knowledge of worldwide affairs of the industry. In short, a round-the-clock service is provided for any information in these areas required by anybody from around the country and abroad. Based on high standards of quality, the training programmes in Pharma, Healthcare and Food GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management, Public Health, Hospital Management, Clinical Research, Pharmacovigilance, Medical Writing, Medical Coding, Nanotechnology, Drug Design and Discovery, Food QA&QC, etc., areas have been approved by Quality Council of India, which is an autonomous body and an accreditation authority for education & vocational training providers under the Ministry of Commerce & Industry, Government of India. IGMPI is duly licensed and certified by Bureau of Indian Standards (BIS) under Bureau of Indian Standards (Conformity Assessment) Regulations 2018.

Accreditation and Awards

Institute of Good Manufacturing Practices India (IGMPI) is registered as a non-profit society with its own Memorandum of Association and bye-laws under The Societies Registration Act, 1860, Government of India. IGMPI is an accredited Vocational Institution of Ministry of Education, Government of India.

The Post Graduate and Executive Diploma programmes of IGMPI in Good Manufacturing Practices, Regulatory Affairs, Intellectual Property Rights, Quality Assurance and Quality Control, Public Health, Nanotechnology, Hospital Management, Product Management, Sales and Marketing Management, Clinical Research, Medical Writing, Drug Discovery and Development, Pharmacovigilance, Medical Coding have been duly assessed and approved by Quality Council of India, Government of India based on fulfillment of QCI's following criteria:

1. Programme Content
2. Programme Design
3. Programme Material
4. Instructors
5. Class size & Attendance
6. Facilities
7. Evaluation of Students
8. Written Examination
9. Certificate

IGMPI is also approved by Food Safety and Standards Authority of India (FSSAI) (FSSAI ID: TPINS18). IGMPI® is licensed by Department of Food Safety & Drug Administration under the Drugs and Cosmetics Act, 1940 and registered under Food Safety and Standards Act 2006.

IGMPI has been conferred with the prestigious "BUREAU OF INDIAN STANDARDS (BIS) AWARD OF HONOUR 2023". QUALITY COUNCIL OF INDIA (QCI) has also conferred IGMPI with D.L. SHAH NATIONAL QUALITY AWARD, Certificate of Merit & ASSOCHAM has conferred IGMPI with the Services Excellence Award based on excellence of its services to the students and training participants.

Bureau of Indian Standards (BIS)

Bureau of Indian Standards (BIS) came into existence through an act of Parliament in 1987. BIS is the National Standard Body of India established under the BIS Act 2016 for the harmonious development of the activities of standardization, marking and quality certification of goods and for matters connected therewith or incidental thereto. The Bureau is a Body consisting of 25 members representing both Central and State governments, Members of Parliament, industry, scientific and research institutions, consumer organizations and professional bodies; with Union Minister of Consumer Affairs, Food and Public Distribution as its President and with Minister of State for Consumer Affairs, Food and Public Distribution as its Vice-President.

Quality Council of India (QCI)

Quality Council of India is set up by the Government of India to establish and operate national accreditation structure and promote quality through National Quality Campaign. QCI is registered as a non-profit society with its own Memorandum of Association. QCI is governed by a Council of 38 members and Chairman of QCI is appointed by the Prime Minister on recommendation of the industry to the government. The Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, is the nodal ministry for QCI.

International Recognition

For providing its education and training services to overseas students, IGMPI is registered with the Directorate General of Foreign Trade, Government of India and our Export Import Code is AADCI7680Q.

IGMPI is an Institutional Member of the International Society for Quality in Health Care

Bureau of Indian Standards (BIS) is a member of International Organization for Standardization (ISO) and through the Indian National Committee (INC) which is a member of International Electrotechnical Commission (IEC). BIS is also a member of regional standards bodies like Pacific Area Standards Congress (PASC) and South Asian Regional Standards Organization (SARSO). India started taking part in IEC from 1911 and subsequently the then Indian Standards Institution (now BIS) took over the responsibility of Indian National Committee of IEC(INC-IEC) in 1949. Since then the INC-IEC is actively participating in the activities of the IEC both at the policy level and technical work and carrying out the responsibilities as member body of IEC Council. India is a member in Standards Management Board (SMB) of IEC since 2015.BIS has also signed Bilateral Cooperation Agreements (BCA)/Mutual Recognition Agreements (MRA) with the National Standards Bodies of several countries like Afghanistan, Bangladesh, Belarus, Egypt, European Union , Germany, Ghana, Greece, Indonesia, Iran, Japan, Jordon, Kenya, Kyrgyzstan, Mali, Mauritius, Nigeria, Russia, Saudi Arabia , Slovakia, Slovenia, Suriname, USA, UAE, Uzbekistan, Viet Nam, Bhutan, Brazil, Israel, Nepal, Pakistan and Sri Lanka.

National Accreditation Board for Certification Bodies (NABCB), Quality Council of India is a member of International Accreditation Forum (IAF) & Pacific Accreditation Cooperation (PAC) as well as signatory to its MLAs for Quality Management Systems, Environmental Management Systems and Product Certification. NABCB is also a Full Member of International Laboratory Accreditation Cooperation (ILAC) & Asia Pacific Laboratory Accreditation Cooperation (APLAC) as well as signatory to its MRAs for Inspection.

Post Graduate Diploma/Executive Diploma in Quality Assurance and Quality Control (Clinical Research as Major)

Over the recent years, the concept of Good Clinical Practice (GCP) has rapidly evolved over the world, with guidelines and regulations now existing not only in the U.S.A. but also in Europe, Scandinavia, Japan, and Australia. The systematic measures laid down in GCP are to ensure that clinical studies are conducted in conformity with strict ethical rules, are performed

According to high-quality standards, and result in authentic, verifiable scientific data. Quality control (QC) in clinical trials means the procedures which insure protection of human subjects from research risk, reliability of the data, and thereby assures internal consistency. The sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are generated, documented (recorded) and reported in compliance with the protocol, GCP, and the applicable regulatory requirements.QA departments often assist in laying down investigator sites selection standards, identifying service providers to be audited, for instance laboratories, drug packaging and supply vendors.

All the above as well as practical knowledge about the subject has been included as case studies, practice modules, e-sessions and lectures, online-classrooms and discussions etc. The sole aim remains to make ready candidates with ample and appropriate knowledge about varied quality issues, concerns, industry needs, techniques, legislative norms and precise knowledge for identifying and overcoming quality related problems arising at work place. With this knowledge the participant can confidently aim to apply for and be a part of healthcare production units, quality check divisions of manufacturing plants and even quality auditing boards and regulatory authorities.

Programme Modules

Module 1: Quality, Quality Assurance and Quality Control in pharmaceutical industries

• Basics of Quality
• Quality Management System
• Need of Quality in Clinical Research
• Introduction to QA and QC 

Module 2: Qualification and Validation

• Introduction to Validation
• Validation Master Plan
• Qualification: DQ, IQ, OQ, PQ, Calibration and Maintenance
• Validation: Process Validation, Analytical Method Validation, Water System Validation, HVAC, Cleaning Validation, Sterilisation Validation, Computer System Validation 

Module 3: Quality Assurance and Quality Control- Possible Problems and Fixes

• Deviations
• Out of Specification (OOS) and Out of Control (OOT)
• Change Control
• Compliance
• CAPA

Module 4: Types of Quality Testing

• Analytical and Bioanalytical Techniques
• Clinical Sample Handling
• Clinical Sample Testing 

Module 5: Quality Testing Tools and Techniques

• Quality Testing Tools
• Quality Assurance Tools
• Statistical Process Control
• Quality Management Tools

Module 6: Quality Certifications, Govt. Regulations, ICH Guidelines and ISO 9000

• Global Regulatory Authorities; USFDA, EMA, UKMHRA, TGA, CDSCO
• ICH, WHO, PIC/S
• International Council on Harmonisation (ICH)
• ICH Guidance on: Quality, Safety, Efficacy and Multidisciplinary
• International Organization for Standardization (ISO)
• ISO 9000, 9001:2015 series 

Module 7: Total Quality Management and GMP, Quality Risk Management, Assessing Quality Concerns at Different Work Units or Areas

• ICH Pharmaceutical Quality System
• Quality Culture
• Quality Policy
• Quality Commitment
• Continuous Improvement: Kaizen, LEAN Six Sigma
• GMP Regulations: USFDA, EU, TGA, ICH, WHO
• ICH Quality Risk Management
• Guidelines on Quality Risk Management: USFDA, WHO, EU
• Quality Defects
• Defect Identification Tools
• Root Cause Investigation
• Deviation, Change Control, CAPA. Complaint and Recall Handling

Module 8: Documentation, Good Documentation Practices, SOPs, Protocols, etc.

• Principles of GDP
• Types of SOPs
• Designing Clinical Trial Protocol
• Protocol deviations and Violations
• Data Integrity
• Analytical Test Protocol, Work Instructions, Checklists, Log books

Module 9: Introduction to Clinical Research Industry and Basics of Clinical Trials

• Clinical Research Industry
• Difference between Clinical Research and Clinical Trials
• Clinical Research terminologies
• General Medical Terminologies

Module 10: Pharmacology-Concepts and Application in clinical trials

• Basics of Pharmacology
• Pharmacodynamics
• Pharmacokinetics
• Routes of Administration
• Dosage forms

Module 11: Drug Development Process

• Drug discovery
• Target Identification
• Lead Identification
• Lead Optimization
• Preclinical studies 

Module 12: Biostatistics- Concepts and Application in Drug Development and Clinical Research

• Defining the Research Problem
• Sampling Design
• Hypothesis testing
• Parametric and Non parametric test 

Module 13: Ethics and Ethical Guidelines for Clinical Trials, and Drug Development Industry

• History of ICH
• ICH Guidelines
• ICH GCP- E6 R2
• ICMR Ethical Guidelines
• Ethics on use of Placebo in Clinical Trials 

Module 14: Regulations Guiding the Clinical Research Industry- History and Basics of National and International Regulatory Bodies

• CDSCO, India
• ICMR, India
• USFDA, USA
• EMEA, Europe
• MHRA, UK
• TGA, Australia 

Module 15: Outsourcing Clinical Trials, functioning of Clinical Research Organisations

• Stakeholders in Clinical Trial
• Introduction to CROs
• Roles and Responsibilities of CRO
• QA and QC of outsourced vendors in Clinical Trials 

Module 16: Introduction to Quality Assurance and Quality Control in Clinical Trials

• Introduction to Quality Management System
• Quality Assurance
• Quality Control
• Audits and Inspection 

Module 17: Quality Management System in Clinical Trails

• Difference between QA and QC
• Difference between Audits and Inspection
• Types of Monitoring
• Responsibilities of QA QC Auditor 

Module 18: Various types of Audits in Clinical Trails

• Routine Audits
• For Cause Audits
• Regulatory Audits
• Sponsor Audits 

Module 19: Clinical Trials Audit observations and study of critical observations

• Review of Investigator site documents
• Ethics committee submissions and Notifications
• Site Facilities Audits
• Consequences of Non compliance 

Module 20: Industry Based Case Studies

Eligibility

BTech/Bsc in Biotechnology/ Microbiology/ Botany/ Zoology/ B.Pharm/M Pharm/MSc / MBBS/ BDS/ BHS/ BUMS/ BAMS/ Graduation in Life science disciplines are eligible for the programme.

Programme Duration

The duration to complete this programme is 1 year (Post Graduate Diploma), 6 months (Executive Diploma).

Registration

The registration dates for this programme run by the Institute are updated timely on the webpage. Effective online learning tools incorporated into the design of the webpage make the programme lectures, online live classes and study material easily accessible. This gives a huge window of self-regulated and self-paced performance to the participants.

Programme Deliverables

A comprehensive study material for all the modules in hard copies ensuring the needs of the audience. The accompanying training material is appropriately aligned with the current Industry’s expectations.

• Assignments for all the programme modules for continuous evaluation and guidance.
• Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• Online classes for all the modules will be conducted on the weekends. Moreover, a doubt clearing session will also be scheduled before the examination
• All the efforts are made by IGMPI faculty members to make the entire programme modules easily understandable.
• Assessment and evaluation for all the programme modules in order to enhance the levels of competencies and skills of the participants leading towards the objective of application in the job.
• At the end of each programme modules, the trainers shall obtain feedback from the participants using specially designed questionnaires.
• All learning and training delivery initiatives shall be conducted in English.

Examination and Certification

IGMPI follows a credit system based on all learning activities involved in studying for all PG Diploma, Executive Diploma and Certificate Programmes. Each of your modules is equal to 4 credits. To successfully complete the programme, you will have to earn all the credits assigned to your programme.This programme is approved by Quality Council of India (QCI), Government of India.

All the participants are expected to appear for an online exam and are also obliged to submit assignments after each module. After successful completion, the participants will be awarded Post Graduate Diploma/Executive Diploma in Quality Assurance and Quality Control (Clinical Research as Major) by Faculty of Clinical Research, IGMPI. For all the above-mentioned modules, Online Classes (Online mode) or face-to-face classes (Regular mode), elaborate programme material, self-assessment assignments would be provided by the Institute. Details get updated on the webpage as well.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing with placement assistance to in its participants. Besides, it has a robust placement cell comprised of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. This cell is continuously engaged in promoting the employability of our participants and encouraging the concerned Human Resources department and Hiring Managers to recruit/hire our participants for their vacant positions. The efforts of our placement cell also include helping with professional resume writing & interview skills.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical like IQVIA, Parexel, Syneos Health, Fisher Clinical Services, Dr. Reddy’s Laboratories, Divi’s Laboratories, GVK Biosciences, Avra Labs, SRL Ranbaxy, Torrent Pharmaceutical Ltd., Novartis Life Sciences, Jubilant Lifesciences Ltd., Aurobindo Pharmaceuticals Ltd., Venus Remedies Ltd., etc. The IGMPI’s Corporate Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare industries on regular basis.

Future career prospects

IGMPI offers professional and industry oriented training in Quality Assurance and Quality Control (Clinical Research as Major)thus opening doors for entry into the industry. The functions of the quality assurance department in the case of a particular clinical trial are very diverse.QA departments identify what internal procedures of the research will be audited from initial study design, site and data supervision, statistical evaluation, and the final CSR.This programme adds advantage for those already in the industry as a tag of professional training and those new to the industry feel comfortable with backing of apt and up-to-date information and training required to sustain and grow in the industry.

It is a broad spectrum programme which offers to entail the candidate with knowledge and practically important information about the industry type, working modalities, methodology of trials, techniques of quality control, drug development, post marketing safety checks and all other aspects related to the clinical research industry. With the completion of this programme the candidate gets to select from varied work areas of the industry/sector of his/her interest. Knowing all faces of the industry, candidate can target to specifically enter the drug development, CTs, Data Management, and Regulatory Affairs, Quality Assurance or Post marketing Surveillance teams of various Pharmaceutical companies. Same is true for the professionals who are already a part of the industry but are keen on making lateral movement in their company by shifting to other department.