Good Automated Manufacturing Practice
Encyclopedia
Good Automated Manufacturing Practice (GAMP) is a trademark of the International Society for Pharmaceutical Engineering (ISPE). 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.
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 January 2008.
Other publications in the GAMP series include:
to deal with the evolving U.S. Food and Drug Administration expectations for good manufacturing practice
(GMP) compliance of manufacturing and related systems. Since 1994, the organization entered into a partnership with ISPE and published its first GAMP guide.
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 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
- 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 KingdomUnited Kingdom
The United Kingdom of Great Britain and Northern IrelandIn the United Kingdom and Dependencies, other languages have been officially recognised as legitimate autochthonous languages under the European Charter for Regional or Minority Languages...
to deal with the evolving U.S. Food and Drug Administration expectations for good manufacturing practice
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
(GMP) compliance of manufacturing and related systems. Since 1994, the organization entered into a partnership with ISPE and published its first GAMP guide.
See also
- Corrective and preventive actionCorrective and preventive actionCorrective action and preventive action are improvements to an organization's processes taken to eliminate causes of non-conformities or other undesirable situations. CAPA is a concept within good manufacturing practice...
(CAPA) - Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation SchemePharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation SchemeThe Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme are two international instruments between countries and pharmaceutical inspection authorities...
- Validation (drug manufacture)Validation (drug manufacture)Validation in the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the...
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMEA) - European Federation of Pharmaceutical Industries and AssociationsEuropean Federation of Pharmaceutical Industries and AssociationsEuropean Federation of Pharmaceutical Industries and Associations is a Brussels-based trade union founded in 1978 representing the research-based pharmaceutical industry operating in Europe....
(EFPIA) - Japan Pharmaceutical Manufacturers AssociationJapan Pharmaceutical Manufacturers AssociationThe Japan Pharmaceutical Manufacturers Association or JPMA is the organization representing the research-based pharmaceutical industry operating in Japan.The JPMA has 74 members including 20 overseas affiliates .- See also :...
(JPMA) - Pharmaceutical Research and Manufacturers of AmericaPharmaceutical Research and Manufacturers of AmericaPharmaceutical Research and Manufacturers of America , founded in 1958, is a trade group representing the pharmaceutical research and biopharmaceutical companies in the United States. PhRMA's stated mission is advocacy for public policies that encourage the discovery of new medicines for patients...
(PhRMA) - International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
External links
- ISPE website
- http://www.it-validation.eu IT Pharma Validation Europe