Certificate in GMP (International Perspective)

Pharmaceutical industries across the world manufacture a vast range of medicinal products every day to support global healthcare systems. Ensuring their quality, safety, and efficacy depends on strict adherence to Good Manufacturing Practices (GMP), which form the foundation of pharmaceutical quality systems. Internationally, GMP implementation is governed by major regulatory authorities such as the U.S. Food and Drug Administration (USFDA) under 21 CFR Parts 210 and 211, and the European Medicines Agency (EMA) through the EU-GMP guidelines (EudraLex Volume 4). These regulations establish comprehensive requirements for premises, equipment, personnel, documentation, and manufacturing operations to ensure that every product is consistently produced and controlled to meet the intended quality standards.

GMP compliance under USFDA and EU-GMP frameworks assures the integrity, safety, and consistency of pharmaceutical products by emphasizing process validation, data integrity, quality control, and risk management throughout the product lifecycle. Adhering to these international standards builds global confidence in the reliability of medicines and ensures their acceptability across regulated markets. Aligning with these frameworks also enhances a manufacturer’s international credibility, facilitating global trade and patient safety. Thus, GMP from an international perspective safeguards public health and reinforces trust in pharmaceutical quality systems worldwide.

This program will enable the participants to:

• Understand the principles and scope of international GMP as per USFDA and EU guidelines.
• Gain knowledge of USFDA 21 CFR Parts 210 & 211 and EudraLex Volume 4 requirements for pharmaceutical manufacturing.
• Learn how GMP ensures product quality, safety, and efficacy across global markets.
• Develop the ability to implement quality assurance systems, documentation controls, and validation processes in compliance with international GMP.
• Recognize the role of GMP in regulatory compliance, inspection readiness, and market authorization.
• Appreciate the harmonization of GMP among WHO, USFDA, EMA, and PIC/S for global pharmaceutical standardization.
• Apply GMP principles to maintain product integrity, minimize manufacturing risks, and promote continuous improvement in pharmaceutical quality systems.

Target Audience

The Certificate Program in GMP (International Perspective) is designed for professionals and students seeking to build or enhance their expertise in pharmaceutical manufacturing and regulatory compliance. It is ideal for:

• Pharmaceutical manufacturing professionals involved in production, quality assurance, and quality control.
• Regulatory affairs executives aiming to understand global GMP requirements.
• R&D and validation specialists seeking to align laboratory and process practices with international GMP standards.
• Auditors and compliance officers responsible for ensuring adherence to international GMP regulations.
• Academicians and postgraduate students in pharmacy, life sciences, and biotechnology aspiring to enter the pharmaceutical quality and manufacturing sector. 

Certified Study Resources

Module 1: Introduction to International GMP

Module 2: USFDA GMP Requirements

Module 3: EU-GMP Guidelines

Module 4: Quality Assurance, Validation, and Data Integrity

Module 5: Regulatory Inspections and Compliance Management

Module 6: Global GMP Harmonization and Emerging Trends

Eligibility

Graduates in any discipline are eligible for our Post Graduate Diploma, Executive Diploma and Professional Certification Programmes.

Programme Duration

The duration to complete this programme is 5 days

Programme Mode

Registration is currently open for Part-time (Online Live Classes) mode.

Programme Deliverables

The accompanying training is appropriately aligned with the current Industry’s expectations.

• Interactive or online live sessions on all key areas of the programme giving all flexibility to the participants.
• 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.

Assessment & Certification

All the participants are expected to appear for online assessment. After successfully qualifying the examination, the participants will be awarded Certificate in GMP (International Perspective) by Faculty of Pharmaceutical Sciences, IGMPI.

Placement Assistance & Corporate Relations

The Institute has partnered with many organizations for providing placement assistance to its participants. The robust placement cell comprises of senior level Human Resources professionals and Talent Acquisition experts which maintains close links with business and industry. We are engaged in promoting the employability of our participants by maintaining good rapport and relation with HR cell and recruiting managers of leading food and agriculture companies across the globe. The efforts of our placement cell also include helping with professional resume writing, interview skills & conducting mock interviews etc.

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare like Dr. Reddy's Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Bliss GVS Pharma, SeQuent, Mankind, Beryl Drugs, Allergy Therapeutics, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon 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 Prospects

Professionals certified in International GMP (USFDA & EU-GMP) have excellent career prospects in the global pharmaceutical and biopharmaceutical industries. They can pursue roles in quality assurance, quality control, regulatory affairs, validation, auditing, and compliance management across multinational companies, contract manufacturing organizations (CMOs), and clinical research organizations (CROs). With increasing regulatory harmonization between USFDA, EMA, WHO, and PIC/S, skilled GMP professionals are in high demand to ensure global compliance, maintain data integrity, and support inspection readiness. This certification enhances employability, equips professionals for leadership roles in quality systems and regulatory affairs, and enables participation in international projects, thereby contributing to patient safety, product reliability, and global market access.

GMP professionals are seen in all different types of domain which include QA GMP Manager, Manufacturing chemist, Warehouse Manager, Pharmaceutical GMP Administrator, Data Integrity Specialist and many more in reputed companies.

View Prospectus

Apply Online

Last date for submitting completed Application Form: 11:59 PM 24^th Oct 2025.

For further enquiries, call or write to us on:
18001031071 (Toll Free -9:00 am to 5:30 pm IST-except on Central Government holidays)/ info@igmpi.ac.in