Good Automated Manufacturing

Practice
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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.[1] 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.

Contents
 1 GAMP Guidance
 2 History
 3 See also
 4 References

 5 External links

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.[2]
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.[3] 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.[4]

See also
 Corrective and preventive action (CAPA)
 Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-
operation Scheme
 Validation (drug manufacture)
 International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH)
 European Medicines Agency (EMEA)
 European Federation of Pharmaceutical Industries and Associations (EFPIA)
 Japan Pharmaceutical Manufacturers Association (JPMA)
 Pharmaceutical Research and Manufacturers of America (PhRMA)

References
1. ^ "ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good
Automated Manufacturing Practice (GAMP)". International Society for
Pharmaceutical Engineering. 25 September 2011. Retrieved 28 February 2012.
2. ^ "GAMP 5: A Risk-Based Approach to Compliant GxP Computerized
Systems". International Society for Pharmaceutical Engineering. Retrieved 28
February 2012.
3. ^ Smith, Paul (1 December 2008). "20th Anniversary Special Feature:
Validation and qualification". Pharmaceutical Technology Europe 20 (2).
Retrieved 28 February 2012.
 4. ^ DeSpautz, Joseph; Kenneth S. Kovacs; Gerhard Werling (11 March 2008).
"GAMP Standards For Validation Of Automated Systems". Pharmaceutical
Processing. Retrieved 28 February 2012.

External links
 ISPE website
 [1] IT Pharma Validation Europe