BASIC UNDERSTANDING ON GMP
What is GMPs ?
Good Manufacturing Practices
A part of Quality Systems to assure each part of the batch/product, each batch and each product manufactured, are consistently meeting the predetermined specification for their intended use.
Why GMP ?
1937 Sulphanilamide Elixir Tragedy
- Sold as a powder – change to liquid orals
- Diethylene Glycol used to suspend the drug
- 100 DEATH – due to renal failure
- Food, Drug and Cosmetic Act 1938 (US)
- Food, Drug and Cosmetic Act 1940 (India)
1960 Thalidomide Disaster
- Major Teratogenic Problem
- Exhaustive enquiry
- Extended investigation to Pre clinical / clinical test & R&D
Concept & Development
GMP is phrase created in 1960s to encompass requirements for Manufacturing and Packing
Focus is safe and effective medicines
Originally, GMPs were based upon the best practices of the industry. As technology and practices improved, the GMPs evolved as well.
In the U.S., cGMPs were formally introduced in 1963 and significantly rewritten in the 1970’s.
Canadian drug GMPs exist in various forms in the 1950’s-1970’s before being published in their current form in the 1980’s.
For more please Download PPT File …..
BASIC UNDERSTANDING ON GMP PPT
