Food and Drugs Administration, (FDA) Haryana, India. |
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Last Updated on December 31, 2023 by The Health Master
Introduction:
The industry like pharmaceuticals, cosmetics, medical devices and homoeopathic are a highly regulated sector that deals with the production, testing, and distribution of drugs, cosmetics, medical devices and homoeopathic medicines.
Good manufacturing practices (GMP) are essential for ensuring the quality and safety of these products.
In this article, we will discuss what GMP, cGMP, and WHO-GMP are, and how they differ from each other.
What is GMP?
GMP is a set of guidelines established by regulatory authorities to ensure that pharmaceutical products are consistently produced and controlled according to quality standards.
It encompasses all aspects of the manufacturing process, from raw materials to finished products, and includes personnel, equipment, facilities, and processes.
What is cGMP?
cGMP stands for current good manufacturing practices. It refers to the current set of GMP guidelines established by regulatory authorities, such as the US Food and Drug Administration (USFDA), the European Medicines Agency (EMA), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
cGMP includes all the requirements of GMP and additional regulations that have been developed to keep up with advances in technology and knowledge.
What is WHO-GMP?
WHO-GMP stands for World Health Organization-Good Manufacturing Practices.
It is a set of guidelines developed by the WHO to ensure that pharmaceutical products are consistently produced and controlled according to quality standards.
The WHO-GMP guidelines are based on the same principles as GMP and cGMP, but they are specifically designed to meet the needs of developing countries.
How do they differ?
GMP, cGMP, and WHO-GMP are all based on the same principles of quality assurance, but they differ in their scope and application.
Here are some of the key differences:
- GMP is a general set of guidelines established by regulatory authorities, while cGMP and WHO-GMP are specific sets of guidelines based on the current state of technology and knowledge.
- cGMP includes all the requirements of GMP and additional regulations that have been developed to keep up with advances in technology and knowledge, while WHO-GMP is specifically designed to meet the needs of developing countries.
- While GMP and cGMP are widely accepted and implemented globally, WHO-GMP is mainly used in developing countries.
- GMP and cGMP apply to all aspects of the manufacturing process, while WHO-GMP focuses mainly on the quality standards of the products.
Conclusion:
Good manufacturing practices (GMP), current good manufacturing practices (cGMP), and World Health Organization-good manufacturing practices (WHO-GMP) are all essential for ensuring the quality and safety of pharmaceutical products.
While they share the same principles, they differ in their scope and application.
Pharmaceutical companies must comply with the appropriate set of guidelines to ensure that their products are safe, effective, and of high quality.
Licensing procedure for manufacturing of Drugs
Procedure to obtain license for manufacturing of Cosmetics
Procedure to obtain license for manufacturing of Homoeopathic Medicines
Procedure to obtain license for manufacturing of Medical Devices
Procedure to obtain License to Manufacture drugs for testing and analysis purposes
Procedure to obtain license for Commercial Testing Laboratories
Procedure to obtain license for Blood Centre (Blood Bank)
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