Good Automated Manufacturing Practice

Good Automated Manufacturing Practice (GAMP) is a technical sub-committee of the International Society of Pharmaceutical Engineering (ISPE). The goal of the committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry. The GAMP committee organizes training seminars for its members.

GAMP Guidelines
The GAMP publishes a series of Good Practice Guides for its members on several topics involved in drug manufacturing. The most well-known is the The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture.

Other guidelines are:
 * Calibration Management
 * Global Information Systems
 * IT Infrastructure Control and Compliance
 * A Risk-Based Approach to Compliant Electronic Records and Signatures (Part 11)
 * Validation of Laboratory Computerized Systems

History
GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving FDA expectations for Good Manufacturing Practice (GMP) compliance of manufacturing and related systems. Since 1994, the organization entered into a partnership with the ISPE and published its first GAMP guidelines.