gmp in pharmaceutical Industry FDA guidelines WHO guidelines

GMP in Pharma industry

1. GMP IN PHARMA INDUSTRIES Presented By Raichel Nivetha . X

2. DEFINITION OF GMP GMP is a set of regulations that ensures the quality of drugs, medical devices, blood, and some types of food. The regulations cover manufacturing, facilities and controls for the manufacturing, processing, packaging or holding of a drug product.

3. What is GMP? 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 regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products.

4. The Origin It was published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments . These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined under FDA 21 CFR Part 210-211 .

5. The first set of Good Manufacturing Practices (GMP) regulations were published in 1963. These regulations are meant to guide companies in the production of safe and effective drugs.

6. Why is GMP important? GMPs are important because consumers cannot easily detect an unsafe or ineffective product simply by looking, smelling or touching it. GMP testing, typically performed on small samples from a batch, ensures that the rest of the batch provides the high quality medication or supplementation desired by these consumers.

7. Annual Product Quality Reviews Complaint handling and Trending Self-inspection Tools of gmp

8. The cycle

9. Who regulate the GMP? MasterControl Inc. is a GxP process management software provider that helps regulated companies attain and sustain compliance with good manufacturing practice (GMP) regulations. GMP regulations are set forth to ensure the quality and safety of life science products.

10. Good manufacturing practices, along with good agricultural practices , good laboratory practices and good clinical practices , are overseen by regulatory agencies in the India, United Kingdom, United States, Canada, Europe, China, and other countries.

11. Conclusion: Poor quality medicines are not only a health hazard, but a waste of money for both governments and individual consumers. Most countries will only accept import and sale of medicines that have been manufactured to internationally recognized GMP. The GMPs are not checklists. They do not describe how work is to be performed, instead they define the required outcome of the work performed.

12. REFERENCES: https://ispe.org/initiatives/regulatory-resources/gmp https://www.who.int/medicines/areas/quality_safety/quality_assurance/gmp/en/ http://blog.fisherbioservices.com/why-gmp-an-explanation-of-good-manufacturing-practice

13. THANK YOU