WHO: Non-Sterile Process Validation
The World Health Organization (WHO) has published the revised draft of the Supplementary Guideline on Good Manufacturing Practices: Validation Appendix 7: Non-sterile Process Validation.
Further to the supplementary guideline on good manufacturing practices: validation (WHO Technical Report Series, No. 937), additional guidelines to support current approaches in good manufacturing practices (GMP) are published to further support the scope of process validation (also referred to as process qualification) linked to quality risk management and quality by design principles as described by WHO and the International Conference on Harmonisation (ICH).
This revised guideline allows for different approaches in process validation. The principles described in this guideline are mainly applicable to non-sterile finished pharmaceutical dosage forms. Similar approaches may be applicable to active pharmaceutical ingredients (APIs) and sterile products.
The validation should cover all manufactured strengths of a product and 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. 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. Retrospective validation is no longer an option. This corresponds to the draft of the revised Annex 15 of the EU GMP Guide.
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