Good Manufacturing Practices (GMP)

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: 

• Unexpected contamination of products, causing damage to health or even death;
• Incorrect labels on containers, which could mean that patients receive the wrong medicine; 
• Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects. 

Why is GMP important? 

• Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers. 

Poor quality medicines can damage health

• A poor quality medicine may contain toxic substances that have been unintentionally added. 
• A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect. 

GMP helps boost pharmaceutical export opportunities 

• Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. 
• Governments seeking to promote their countries' export of pharmaceuticals can do so by making GMP mandatory for all pharmaceutical production and by training their inspectors in GMP requirements. 

Contents of this course:

Module 1: Principles of GMP

• Why GMP?
• What is GMP?
• Threats of the quality
• Contamination and preventing it
• Mix-up and how to avoid it
• Damage and how to prevent it
• The need for checks
• Documentation and what it requires
• Test

Module 2: GMP-procedures

• Protective clothing + test
• Cleaning + test
• Warehouse + test
• Laboratory + test
• Clean areas + test

Module 3: Practical cases

• 23 practical cases in a pharmaceutical company.