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Good Automated Manufacturing Practices, known as GAMPs, are guidelines provided for both users of automated pharmaceutical products and manufacturers of these products. GAMP was established in 1991 by the pharmaceutical industry profession in the UK to meet the needs of the industry and to improve the changing expectations of regulatory bodies in Europe and to provide an understanding of how pharmaceutical companies should validate their computer systems.
GAMP-5 or version 5 of GAMP is the latest standard of guidelines and was published in February 2008 by the International Society for Pharmaceutical Engineering (ISPE) a GAMP partner company.
Concept of GAMP 5 in Pharmaceuticals This version is considered as the most structured and project oriented approach and is more inclined towards ensuring computerized system risk control and quality management in manufacturing and supply of pharmaceutical products.
