Difference between revisions of "Template:Article of the week"

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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.
'''[[ISO/IEC 17025]]''' is an [[International Organization for Standardization]] (ISO) standard used by testing and calibration laboratories to provide a basis for accreditation of laboratory quality systems. There are many commonalities with the [[ISO 9000]] family of standards, but ISO/IEC 17025 adds in the concept of competence to the equation, applying directly to those organizations that produce testing and calibration results.  


GAMP is largely about automated system validation. In October 2014, Irish tech company Dataworks Ltd. described it as such:
ISO/IEC 17025:1999 was issued by the ISO in late 1999 and was internationally adopted in 2000. A second release was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000 version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior management, as well as explicit requirements for continual improvement of the management system itself, particularly communication with the customer.


"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 />
The ISO/IEC 17025 standard itself comprises five elements: scope, normative references, terms and definitions, management requirements, and technical requirements. In particular the management and technical requirements are the most important sections, with the management requirement section detailing the operation and effectiveness of the quality management system within the laboratory and the technical requirements section detailing the factors which determine the correctness and reliability of the tests and calibrations performed in laboratory. ('''[[ISO/IEC 17025|Full article...]]''')<br />
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''Recently featured'': [[End-stage renal disease facility]], [[Genome informatics]], [[Cancer informatics]]
''Recently featured'': [[Good Automated Manufacturing Practice]], [[End-stage renal disease facility]], [[Genome informatics]]

Revision as of 18:25, 23 February 2015

US Navy 100714-N-3852A-118 Hull Systems Technician monitors nitrogen tank.jpg

ISO/IEC 17025 is an International Organization for Standardization (ISO) standard used by testing and calibration laboratories to provide a basis for accreditation of laboratory quality systems. There are many commonalities with the ISO 9000 family of standards, but ISO/IEC 17025 adds in the concept of competence to the equation, applying directly to those organizations that produce testing and calibration results.

ISO/IEC 17025:1999 was issued by the ISO in late 1999 and was internationally adopted in 2000. A second release was made on May 12, 2005 after it was agreed that it needed to have its wording more closely aligned with the 2000 version of ISO 9001. The most significant changes introduced greater emphasis on the responsibilities of senior management, as well as explicit requirements for continual improvement of the management system itself, particularly communication with the customer.

The ISO/IEC 17025 standard itself comprises five elements: scope, normative references, terms and definitions, management requirements, and technical requirements. In particular the management and technical requirements are the most important sections, with the management requirement section detailing the operation and effectiveness of the quality management system within the laboratory and the technical requirements section detailing the factors which determine the correctness and reliability of the tests and calibrations performed in laboratory. (Full article...)

Recently featured: Good Automated Manufacturing Practice, End-stage renal disease facility, Genome informatics

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