Glossary

 

GAMP - Good Automated Manufacturing Practice

 

A guide to best practices published by a technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE). The goal of the community is to promote the understanding of the regulation and use of automated systems within regulated industry.

 

FDA - Food and Drug Administration

 

The Food and Drug Administration is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.

Useful links:

 

ISPE

www.ispe.org

 

FDA

www.fda.gov