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.

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.

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.

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

• GAMP Global Steering Committee - Global governance
  • GAMP Americas (USA)
    • GAMP Puerto Rico
  • GAMP Brazil
  • GAMP Europe
    • GAMP Benelux
    • GAMP D-A-CH
    • GAMP Francophone
    • GAMP Italy
    • GAMP Nordic
    • GAMP Poland
    • GAMP Spain
    • GAMP UK
    • GAMP Ireland
  • GAMP Japan

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

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