Which GMPs Apply Since Most Phase I Drugs are Exempt from Full GMP Requirements, and What IND Data Requirements Are Necessary as a Result?

Which GMPs Apply Since Most Phase I Drugs are Exempt from Full GMP Requirements, and What IND Data Requirements Are Necessary as a Result?

GMP requirements from the FDA

GMP requirements from the FDA FDA Good Manufacturing Practices (GMP) is a set of guidelines issued by the FDA for various disciplines. There are GMP requirements FDA has for areas ranging from cosmetics to food to pharmaceuticals to API’s. Why GMP’s? Why are GMP requirements FDA has put in place necessary? It is for the […]

History of FDA GMP requirements

History of FDA GMP requirements The FDA has Good Manufacturing Practices (GMP) requirements for a range of items. One of them is Active Pharmaceutical Ingredients (API). FDA GMP requirements are established under the FDA Act. In Sec. 501 (a) (2) (B) of the Act (21U.S.C. 351(a) (2) (B)); the FDA seeks to establish API as […]

FDA API GMP requirements –current quality guidelines

FDA API GMP requirements –current quality guidelines The US FDA has set out Good Manufacturing Practices (GMP) requirements for a number of products. The Food, Drug and Cosmetic Act, a US law,empowers the FDA with authority to regulate a number of industries. Accordingly, the FDA GMP requirements and guidelines exist for a clutch of products […]