Revised Draft of Supplementary Guideline for non-sterile process validation published by WHO

The revised draft of the Supplementary Guideline on Good Manufacturing Practices: Validation Appendix 7: Non-sterile Process Validation has been published by WHO

Additional guidelines support current approaches in GMP to support the scope of process validation which are linked to quality risk management and quality by design principles as described by WHO and the International Conference on Harmonization (ICH).The revised guideline covers different approaches in process validation. The principles are applicable to non-sterile finished pharmaceutical dosage forms. Similar approaches may be applicable to active pharmaceutical ingredients (APIs) and sterile products.

There are different approaches to process validation which include: traditional process validation (consisting of prospective and concurrent validation); process design followed by process qualification and continued process verification; or a combination of traditional process validation and the approach described in this guideline.

The validation should cover all manufactured strengths of a product. The extent of validation at each manufacturing site should be based on risk assessment. A matrix approach or bracketing may be acceptable based on appropriate risk assessment.