Thursday, January 17, 2008

GAMP 5 on Desks -

The number of significant initiatives, from both international regulators and industry, have influenced thinking on how validation in the regulated GxP environment might be achieved in the most effective and efficient manner. This has led to focusing validation on those items that affect product quality and public health using a risk- and science-based approach.
There has also been a major move toward the use of products and packaged solutions and away from bespoke developments.
As a result the GAMP Council is planning to revise the GAMP Guide to reflect current regulatory expectations and current industry good practice while maintaining continuity with GAMP 4 principles. The Guide will be focus on the use of products and packaged solutions rather than custom (bespoke) systems.
The emphasis will be on providing a cost effective approach to validation that will demonstrate that a computerized system is fit for its intended use, while avoiding unnecessary work. To support this, new and updated guidance is in development on the following aspects:
  • Scaleable validation approach driven by risk to product quality, patient safety and regulatory compliance including supporting records.
  • Integration of validation activities within a complete life cycle approach as part of a Quality Management System (QMS), from concept through development and operation to retirement.
  • Use of supplier documentation and knowledge wherever possible to avoid repetition and duplication.
  • Importance of clear requirements based on a thorough understanding of the process and product.
  • Improving validation efficiency by enabling practical and efficient interpretation of GAMP guidance

Concepts and terminology will be aligned with recent regulatory developments including:

  • FDA cGMPs for the 21st Century Initiative and associated guidance.
  • PIC/S Guidance.
  • ICH (International Council for Harmonization) Guidance Q9 and Q10.
  • Emerging standards such as those produced by the ASTM E55 Committee

Source : ISPE, GAMP COP.

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