Good automated manufacturing practice (GAMP) is both a technical subcommittee of the International Society

for Pharmaceutical Engineering (ISPE) and a set of guidelines for manufacturers and users of automated
systems in the pharmaceutical industry. More specifically, the ISPE's guide The Good Automated Manufacturing
Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of
principles and procedures that help ensure that pharmaceutical products have the required quality. One of the
core principles of GAMP is that quality cannot be tested into a batch of product but must be built into each stage
of the manufacturing process. As a result, GAMP covers all aspects of production; from the raw materials,
facility and equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are essential
for processes that can affect the quality of the finished product.

A group of pharmaceutical professionals have banded together to create the GAMP Forum, which is now a
technical sub-committee, known as the GAMP COP (community of practice) 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 the pharmaceutical industry. The GAMP COP organizes
discussion forums for its members. ISPE organises GAMP-related training courses and educational seminars.
Several local GAMP COPs, such as GAMP Americas, GAMP Nordic, GAMP DACH (Germany, Austria,
Switzerland), GAMP Francophone, GAMP Italiano, GAMP Benelux (Belgium, Netherlands, Luxembourg) and
GAMP Japan bring the GAMP community closer to its members in collaboration with ISPE's local affiliates in
these regions.

GAMP Guidance
ISPE has published a series of good practice guides for the industry on several topics involved in drug
manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for
Validation of Automated Systems in Pharmaceutical Manufacture. The last major revision (GAMP5) was
released in February 2008.

Other publications in the GAMP series include:

GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems
GAMP Good Practice Guide: Calibration Management
GAMP Good Practice Guide: Electronic Data Archiving
GAMP Good Practice Guide: Global Information Systems Control and Compliance
GAMP Good Practice Guide: IT Infrastructure Control and Compliance
GAMP Good Practice Guide: Testing of GxP Systems
GAMP Good Practice Guide: Validation of Laboratory Computerized Systems
GAMP Good Practice Guide: Validation of Process Control Systems
History
GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving U.S. Food and Drug
Administration expectations for good manufacturing practice (GMP) compliance of manufacturing and related
systems. GAMP published its first guidance in 1994. Soon afterwards the organization entered into a
partnership with ISPE, formally becoming part of ISPE in 2000. GAMP has enjoyed the support of numerous

regulatory authorities over the years spanning the United States, Europe, and Japan and is now a recognised
good practice worldwide.