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Home Market News Rx-360 summary of the WHO Draft Guidelines on Qualification and Validation
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4 Jul 2016

Rx-360 summary of the WHO Draft Guidelines on Qualification and Validation

In addition to the main guidelines, appendices on validation and qualification are included.

Rx-360 has published a summary of WHO's recently issued draft document titled "Guidelines on Validation". These guidelines (i.e., the main text included in this working document) cover the general principles of validation and qualification.

These guidelines focus mainly on the overall concept of validation and are not intended to be prescriptive in specific validation requirements. This document serves as general guidance only and the principles may be considered useful in its application in the manufacture and control of starting materials and finished pharmaceutical products (FPPs), as well as other areas. Validation of specific processes and systems, for example, in sterile product manufacture, requires much more consideration and a detailed approach that is beyond the scope of this document. The general text in this document may be applicable to validation and qualification of premises, equipment, utilities, systems, processes, and procedures.

In addition to the main guidelines, appendices on validation and qualification (e.g., cleaning, computer and computerised systems, equipment, utilities and system, and analytical methods) are included. The draft on the specific topics, the appendices to this main text, will follow. The following is an overview on the appendices that are intended to complement the text of this working document:

  • Appendix 1: Validation of heating, ventilation and air-conditioning systems — will be replaced by cross reference to WHO Guidelines on GMP for HVAC systems for considerations in qualification of HVAC systems (update — working document QAS/15.639/Rev. 1)

  • Appendix 2: Validation of water systems for pharmaceutical use — will be replaced by cross-reference to WHO Guidelines on water for pharmaceutical use for consideration in qualification of water purification systems

  • Appendix 3: Cleaning validation — consensus to retain

  • Appendix 4: Analytical method validation — update in process

  • Appendix 5: Validation of computerized systems — update in process

  • Appendix 6: Qualification of systems and equipment — update in process

  • Appendix 7: Non-sterile process validation — update already published as Annex 3, WHO Technical Report Series, No. 992, 2015

  • Comments on this draft document are due by 12 July 2016.

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