GAMP Guideline

What is the meaning of GAMP?

GAMP stands for “Good Automated Manufacturing Practice,” which is released by ISPE.

What is the meaning of ISPE and What do they do?

ISPE stands for “International Society for Pharmaceutical Engineering”.

The International Society for Pharmaceutical Engineering (ISPE) is a non-profit organization dedicated to advancing scientific, technical, and regulatory advances in the pharmaceutical industry.

ISPE is the global industry leader in linking pharmaceutical expertise to bring manufacturing and supply chain innovation, operational excellence, and regulatory insights to help the industry develop, manufacture, and deliver quality medicines to patients more reliably.

They provide training and knowledge to the Pharma Industries for Automation in Manufacturing Practices.

What is GAMP 5® guidelines?

GAMP is a short form for “Good Automated Manufacturing Practice”.

ISPE: International Society for Pharmaceutical Engineering.

GAMP 5® (ISPE) is a structured technique to testing and validating automated systems. Version 5 of GAMP (GAMP 5 ®) is currently the most up-to-date, with no plans for a version 6 in the works. The emphasis is greater on risk control and quality management than in earlier editions.

Companies in regulated industries can assure automated system quality by accurately interpreting and following the GAMP 5® standard. They will also find it much easier to pass audits and regulatory inspections. GAMP 5® is a subject in which QbD has a lot of knowledge and experience. We assist businesses in a variety of ways, including:

  • Ensure that the automated systems and processes to be delivered are well-defined.
  • From a quality standpoint, implement a system life cycle approach.;
  • Make the Life Cycle’s Activities Scalable
  • Apply scientifically oriented Risk Management;
  • Utilize as much information and documentation as possible from vendors.

What is the current version of GAMP?

Version 5 of GAMP (GAMP 5 ®) is currently the most up-to-date. It was released in February 2008.

What are the publications in the GAMP series?

Publications in the GAMP series include:

  • 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

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Acronyms and Abbreviations

Reference:

https://ispe.org/publications/guidance-documents/gamp-5

https://en.wikipedia.org/wiki/Good_automated_manufacturing_practice

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation

https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice

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