Good Manufacturing Practices (GMP) – 2012 and Beyond

Introduction

Since the publication of criteria for the production of finished pharmaceuticals in 1963 by FDA, USA, followed by the formulation of the maiden issue of British GMP (Orange Guide), several other official bodies in a number of countries have published GMPs. Over the intervening years GMP guidelines have been revised, updated and additional guidelines have been adopted as supplement to the original guidelines. Currently GMP is regarded as the combination of all the essential and best practices used in the manufacture of drugs and medicinal products as well as processed food to fulfill certain requirements. Recently UK, ASEAN countries and many national bodies have updated their country’s GMP guidelines. United States has recently updated its own version and published as cGMP. WHO GMP has also been updated recently.

How participants will benefit after the course:
The GMP Training Program will help you refresh your existing knowledge on GMP and provide you with in-depth knowledge and insight into the subject. It will supplement the previous concept and knowledge up-to-date. The training will also give the participants the ability to identify the shortcomings towards the implementation of acceptable GMPs in participant’s own place of work. It will also enable the participants to undertake periodic GMP compliance audit, and may serve as training for the trainers (TOT) on GMP.

Methodology

Interactive discussion, PowerPoint Presentation, Question and answer session.

Contents of Training:

Day 1:
1. What GMP is all about
2. Essence, objective and scope of GMP
3. Evolution of GMPs
4. Types of GMP
5. Basic requirements and guidelines of GMP for Quality management in pharmaceutical industry
6. Personnel
7. Training
8. Basic requirements and guidelines of GMP for Premises (general and special requirements)
9. Equipment
10. Batch documentation
11. Production
12. Quality control and GLP

Day 2:
1. Basic requirements and guidelines of GMP for Contract manufacture and analysis
2. Handling of product complaints
3. Product recall
4. Handling of returned products
5. Guidelines of GMP for manufacturing special products
6. Guidelines of GMP for processed foods and dairy products
7. Cleaning and analytical procedures validation
8. GMP and validation
9. GMP and ISO 9000 Quality Management System - WHO’s recommendations
10. Non-conformity, correction and corrective and preventive actions
11. Hazards Analysis and Risk Assessment (HIRA) in food manufacturing
12. Self - inspection and Quality Audits
13. GMP Compliance Audit and Audit Checklist

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