GAMP 5 - Good Automated Manufacturing Practice

MasterControl GAMP 5 Offers Good Automated Manufacturing Practice Guidelines for Manufacturing Companies to Comply with Regulated Environments

MasterControl's Quality Management Systems are designed by industry practitioner for automating the GAMP 5 process in any organization. A Quality Management Software system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated GAMP 5 system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.

GAMP®5: A Risk-based Approach to Compliant GxP Computerized Systems

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How the White Paper about GAMP 5 can help You

The International Society for Pharmaceutical Engineering (ISPE) issued the worldwide release of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems in March of 2008. The updated manual for GAMP 5 provides guidelines for good automated manufacturing practices that are referenced in markets around the world, including North and South America, Europe, and Japan.

The white paper that you can download above offers GAMP 5 guidelines and offers ideas on how companies can utilize the processes and templates in the updated manual for GAMP 5 to minimize validation efforts and improve by good automated manufacturing practices.

A variety of subjects related to good automated manufacturing practice are covered in detail in the white paper, specifically:

  • A brief history of GAMP
  • The rationale for GAMP 5
  • The driving forces behind GAMP 5
  • A comparison of GAMP 5 and GAMP 4 -- specifically how they differ
  • Tips on how companies can leverage GAMP 5 to their greatest benefit

Five Key Concepts of GAMP 5

The white paper also outlines and explains the five key concepts behind good automated manufacturing practice 5

  • Product and Process Understanding
  • Lifecycle approach within QMS
  • Scalable Lifecycle Activities
  • Science Based Quality Risk Management
  • Leveraging Supplier Involvement

Other highlights of the GAMP 5 manual covered in the white paper include:

  • Clarified roles
  • Flexibility of format and structure
  • Good automated manufacturing practice for suppliers expectations
  • Supplier assessment and more

For More Information on Good Automated Manufacturing Practice - GAMP 5

For more information about GAMP 5, please feel free to contact a MasterControl representative.