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GAMP®

Since its creation, Kereon AG endorses and applies the approach proposed by the GAMP Community and supports actively the GAMP activities:

  • Co-foundation of GAMP Francophone
  • Edition of the French version of GAMP 4 and GAMP 5 Guides (see below)
  • Participation at various committees and working groups
  • Co-organization and co-moderation of numerous of conferences and Round Tables.

GAMP history

Founded in 1991 in UK, the GAMP Forum - Good Automated Manufacturing Practice - is from the beginning a place for sharing experience regarding all questions related to the compliance of computerized and information systems between representatives of the pharmaceutical industry, suppliers and regulators.

Later the GAMP Forum become a technical subcommittee of ISPE - International Society for Pharmaceutical Engineering - and, since 2005, GAMP is a COP - Community of Practice - with a wide international recognition.

Publication

Since the beginning, the GAMP Forum is working on the development of various Guides for the industry. The purpose of these Guides - which do not represent regulation - is to propose commensurate and consistent approach for fulfilling applicable regulatory requirements to regulated organizations of the health care sector.

Currently, the following GAMP Guides are available:

  • GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems, [CN, DE, EN, FR]
  • GAMP® Good Practice Guides
    • A Risk-Based Approach to Calibration Management, Second edition, [DE, EN]
    • A Risk-Based Approach to Compliant Electronic Records and Signatures, [EN]
    • A Risk-Based Approach to GxP Compliant Laboratory Computerized Systems, Second edition, [EN]
    • A Risk-Based Approach to GxP Process Control Systems (GPCS), Second edition, [EN]
    • A Risk-Based Approach to Operation of GxP Computerized Systems (OGCS), [DE, EN]
    • A Risk-Based Approach to Regulated Mobile Applications, Second edition, [EN]
    • A Risk-Based Approach to Testing of GxP Systems, Second edition, [DE, EN]
    • Electronic Data Archiving (EDA), [EN]
    • Global Information Systems Control and Compliance, [EN]
    • IT Infrastructure Control and Compliance, [EN]
    • Manufacturing Execution Systems - A Strategic and Program Management Approach (MES), [EN]

These documents could be ordered on the ISPE web site. They have been elaborated by various working groups - SIG : Special Interest Group - involving representatives of the regulated industry, suppliers, consultants, and regulators.

Structure

In order to facilitate a well balanced development and an efficient governance of the GAMP Community, the following structure has been established:

Brand

ISPE® and GAMP® are registered marks of the International Society for Pharmaceutical Engineering (ISPE).

Information


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Last update: 2017-01-01

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