WHO publishes draft on Process Validation

WHO published a proposal for revision of appendix 7 (non-sterile process validation) as a subsidiary to the guidelines on Good Manufacturing Practices. The Compliance with actual GMP requirements was the reason for this revision. Clearly mentioned are quality risk management principles and quality by design principles with references to WHO and ICH requirements. The text is generally related to non-sterile finished pharmaceutical dosage forms. According to the draft similar approach may be applicable to active pharmaceutical ingredients (APIs) and sterile products. Now the WHO also sets the focus of validation on the life-cycle of process validation which consists of:

• product and process development
• validation of the commercial manufacturing process and
• maintaining the process in a state of control

A risk-based approach and the use of in-line, on-line and/or at-line controls is recommended expressly. The 16-pages-draft consists of 7 chapters and the references:

1. Background and scope
2. Glossary
3. Introduction
4. Process design
5. Process qualification
6. Continued process verification
7. Change control
8. References