It 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.
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. 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 Home Knowledge and Learning ISPE Guidance Documents. Reflecting current regulatory expectations and good practices, the GAMP ® series of Good Practice Guides provide interpretation of regulatory standards to help improve compliance, quality, and efficiency while reducing cost.  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. 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 Gamp is a colloquial, primarily British, term for an umbrella, after the Dickens' character Mrs Sairey Gamp. GAMP may refer to: 1  Girard Academic Music Program, a magnet secondary school in Philadelphia, Pennsylvania. 2  Good Automated Manufacturing Practice in the pharmaceutical industry. 3  Grupa Arhitekata Modernog Pravca, Serbian for  Group of Architects of Modern Expressions  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. 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 noun. An umbrella, especially a large unwieldy one: he stuck his gamp in the hallstand. More example sentences. 1  When the rain began to come down in buckets I thought I had better invest in a gamp, but was deterred by the thought that I already had two lying about somewhere at home and one in my office here.  Specifically, let’s consider the ISPE’s publications: “The GAMP Guide for Validation of Automated Systems in Pharmaceutical Manufacture” and “GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems.” Maintaining environmental conditions within product specifications is a critical part of GxP operations. Overall, a GAMP approach to validation as outlined in this article should increase the lifespan, usability, and compliance of your CMS software. A User Requirements Specifications (URS) document describes what the end user needs a system to do. 1 2 3 4 5 6 7 8. Next. The GAMP (Good Automated Manufacturing Practice) guide version 5 was released in March 2008 and one of the changes was that the classification of software was revised again. This column will look at what the changes mean for the laboratory and whether all of these should be implemented. R.D. McDowall Version 5 of the Good Automated Manufacturing Practice (GAMP) guide (1) was released last year. This publication has been available since 1994, when version 1 was informally published in the UK, and since its inception it has always contained a classification of software. Software Classification Categories. As I mentioned earlier, the software categories in GAMP 5 have been revised (1). To appreciate the scope of these changes fully we need to look at the classification of software from GAMP 4 (2) and compare this with GAMP 5, as shown in Table I. Good Automated Manufacturing Practice (GAMP) came into being as a direct result of the increase in regulatory attention received by the pharmaceutical manufacturing industry during the late nineteen eighties and nineties. In response to this the GAMP forum was set up to promote better understanding and interpretation of the regulations and improve communication within the pharmaceutical industry, it’s suppliers and the various regulators.
https://en.wikipedia.org/wiki/Good_Automated_Manufacturing_Practice http://ispe.org/gamp-good-practice-guides https://en.wikipedia.org/wiki/Good_Automated_Manufacturing_Practice https://en.wikipedia.org/wiki/Gamp https://en.wikipedia.org/wiki/Good_Automated_Manufacturing_Practice http://www.oxforddictionaries.com/definition/english/gamp http://www.vaisala.com/Vaisala%20Documents/White%20Papers/CEN-LSC-G-Using-GAMP-Methods-to-Validate-CMS-Software-B211370EN-A.pdf http://www.spectroscopyonline.com/understanding-and-interpreting-new-gamp-5-software-categories http://www.smbvalidation.com/FAQ/what-is-gamp4.html
what is a gamp