News about GMP/cGMP


WHO: Draft Guidance on Validation

WHO has recently issued a 21-page draft document “Guidelines on Validation” which covers the main principles of validation and qualification. The guidelines are not intended to be prescriptive in specific validation requirements but focus on the overall concept of validation. 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, e. g. sterile product manufacture, are beyond the scope of the guideline.


The guideline will be further complemented by the following appendices:

  • Appendix 3: Cleaning validation - consensus to retain

After the consolidation of comments received, the guidelines will be presented to the 51st meeting of the WHO Expert Committee on Specifications for Pharmaceutical Preparations from 17 – 21 October 2016.


WHO: Draft Guidelines on validation



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