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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. 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. | '''[[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. 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. | ||
GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such: | GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such: | ||
"It is a formal process of thorough documentation, testing, and logical process steps that validate clients' required specifications. The process begins with a user requirements specification for the machine, from which a functional requirement and a design specification are created. These documents then form the basis for the traceability matrix and for the formal testing of internal acceptance, factory acceptance, and site acceptance. Categorising software is used to support the approach to validation based on the difficulty and individuality of the computerised system." ('''[[Good Automated Manufacturing Practice|Full article...]]''')<br /> | |||
('''[[Good Automated Manufacturing Practice|Full article...]]''')<br /> | |||
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''Recently featured'': [[End-stage renal disease facility]], [[Genome informatics]], [[Cancer informatics]] | ''Recently featured'': [[End-stage renal disease facility]], [[Genome informatics]], [[Cancer informatics]] | ||
Revision as of 17:46, 17 February 2015
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. 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.
GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such:
"It is a formal process of thorough documentation, testing, and logical process steps that validate clients' required specifications. The process begins with a user requirements specification for the machine, from which a functional requirement and a design specification are created. These documents then form the basis for the traceability matrix and for the formal testing of internal acceptance, factory acceptance, and site acceptance. Categorising software is used to support the approach to validation based on the difficulty and individuality of the computerised system." (Full article...)
Recently featured: End-stage renal disease facility, Genome informatics, Cancer informatics
