Monday, 29 April 2013

WHO issues guidelines on non-sterile process validation


The World Health Organisation (WHO) has issued guidelines for the revision of the supplementary guidelines on good manufacturing practices: non-sterile process validation. The closing date for comments is May 24th, 2013.

The introduction to the document states:

"This guideline allows for different approaches in process validation. The principles described in this guideline are applicable to non-sterile finished pharmaceutical dosage forms. Thorough knowledge of product and process development studies; previous manufacturing experience; and quality risk management (QRM) principles are essential in the all approaches to process validation as the focus is now on the life-cycle approach. The life-cycle approach links product and process development, validation of the commercial manufacturing process and maintenance of the process during routine commercial production."

In the document it is explained that manufacturers should plan towards implementing the new approach in process validation that should consist of three phases in the product life-cycle.
  • Phase I. Process design
  • Phase II. Qualification and process verificatio
  • Phase IIA. Qualificatio
  • Phase IIB. Continuous process performance verification
  • Phase III. Continued process verification 
The document is designed to form part of the supplementary guidelines on good manufacturing practices: validation. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fortieth report. Geneva, World Health Organization. WHO Technical Report Series, No. 937 (Annex 5), 2006.

To access the document, see WHO.
Posted by Tim Sandle