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Good Automated Manufacturing Practice (GAMP) is een standaard met betrekking tot veiligheid van farmaceutische producten. De term is een handelsmerk van de ISPE (International Society for Pharmaceutical Engineering).
, Good automated manufacturing practice (GAM … 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. 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. ISPE's local affiliates in these regions.
, Der „Good Automated Manufacturing Practice … Der „Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture“ (kurz: GAMP) wurde im Jahre 1994 vom Pharmaceutical Industry Computer Systems Validation Forum (PICSVF), welches sich später in Good Automated Manufacturing Practice Forum (GAMP) umbenannte, in Zusammenarbeit mit der International Society for Pharmaceutical Engineering (ISPE) veröffentlicht. Dieser Leitfaden hat sich zum Standardregelwerk für die Validierung computergestützter Systeme in der pharmazeutischen Industrie (Hersteller und Zulieferer) entwickelt. Die GAMP-Regelwerke haben jedoch keine gesetzliche Bindung. Deshalb sind davon abweichende Formen der Validierung von computerisierten Systemen möglich, was bei vielen Systemen sinnvoll ist. In Ergänzung werden Good Practice Guides zu speziellen Aspekten erstellt, zum Beispiel der Guide „Validation of Process Control Systems“. Seit Ende Februar 2008 ist die aktuelle Version 5 (GAMP 5) verfügbar. Das Dokument muss käuflich erworben werden. Im Dezember 2008 wurde dieser Leitfaden (GAMP 5) ins Deutsche übersetzt. Seit Mitte 2009 ist ebenso eine elektronische Version erhältlich. Bemerkung: Fälschlicherweise wird manchmal der GAMP 5 als eine behördliche Richtlinie angesehen. Es ist ein anerkannter Standard als Leitfaden für die Validierung.tandard als Leitfaden für die Validierung.
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Der „Good Automated Manufacturing Practice … Der „Good Automated Manufacturing Practice Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture“ (kurz: GAMP) wurde im Jahre 1994 vom Pharmaceutical Industry Computer Systems Validation Forum (PICSVF), welches sich später in Good Automated Manufacturing Practice Forum (GAMP) umbenannte, in Zusammenarbeit mit der International Society for Pharmaceutical Engineering (ISPE) veröffentlicht. Dieser Leitfaden hat sich zum Standardregelwerk für die Validierung computergestützter Systeme in der pharmazeutischen Industrie (Hersteller und Zulieferer) entwickelt. Die GAMP-Regelwerke haben jedoch keine gesetzliche Bindung. Deshalb sind davon abweichende Formen der Validierung von computerisierten Systemen möglich, was bei vielen Systemen sinnvoll ist.ich, was bei vielen Systemen sinnvoll ist.
, Good automated manufacturing practice (GAM … 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. 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 acility and equipment to the training and
, Good Automated Manufacturing Practice (GAMP) is een standaard met betrekking tot veiligheid van farmaceutische producten. De term is een handelsmerk van de ISPE (International Society for Pharmaceutical Engineering).
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Good Automated Manufacturing Practice
, Good automated manufacturing practice
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