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Good Automated Manufacturing PracticeFrom Wikipedia, the free
encyclopedia
Good Automated Manufacturing Practice (GAMP) is a trademark of
theInternational Society for
Pharmaceutical Engineering(ISPE).
[1]
The ISPE's guide The Good Automated Manufacturing Practice
(GAMP)Guide for Validation of Automated Systems in Pharmaceutical
Manufacturedescribes 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 thepharmaceutical
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 isThe Good Automated
Manufacturing Practice (GAMP) Guide for
Validation of Automated Systems in Pharmaceutical Manufacture.
The last major revision (GAMP5) was
released in January 2008.
Other publications in the GAMP series include:
GAMP Good Practice Guide: A Risk-Based Approach to Compliant
Electronic Records and Signatures
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
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