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Good Automated Manufacturing Practice

 

Good Automated Manufacturing Practice

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.[1] 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

  • ISPE website
  • [1] IT Pharma Validation Europe

External links

  1. ^ "ISPE Glossary of Pharmaceutical and Biotechnology Terminology - Good Automated Manufacturing Practice (GAMP)". International Society for Pharmaceutical Engineering. 25 September 2011. Retrieved 28 February 2012. 
  2. ^ "GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems". International Society for Pharmaceutical Engineering. Retrieved 28 February 2012. 
  3. ^ Smith, Paul (1 December 2008). "20th Anniversary Special Feature: Validation and qualification". Pharmaceutical Technology Europe 20 (2). Retrieved 28 February 2012. 
  4. ^ DeSpautz, Joseph; Kenneth S. Kovacs; Gerhard Werling (11 March 2008). "GAMP Standards For Validation Of Automated Systems". Pharmaceutical Processing. Retrieved 28 February 2012. 

References

See also

[4] GAMP itself was founded in 1991 in the

History

  • GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems
  • GAMP Good Practice Guide: Calibration Management
  • GAMP Good Practice Guide: Electronic Data Archiving
  • GAMP Good Practice Guide: Global Information Systems Control and Compliance
  • GAMP Good Practice Guide: IT Infrastructure Control and Compliance
  • GAMP Good Practice Guide: Testing of GxP Systems
  • GAMP Good Practice Guide: Validation of Laboratory Computerized Systems
  • GAMP Good Practice Guide: Validation of Process Control Systems

Other publications in the GAMP series include:

ISPE has published a series of good practice guides for the industry on several topics involved in drug manufacturing. The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The last major revision (GAMP5) was released in February 2008.[2]

GAMP Guidance

  • GAMP Guidance 1
  • History 2
  • See also 3
  • References 4
  • External links 5

Contents

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