WHO revised Appendix 7 for Non-sterile Process Validation

The World Health Organization (WHO) has published a proposal for the revision of the supplementary guidelines on GMP: Validation, namely Appendix 7 – Non-sterile Process Validation. The presentation to the WHO Expert Committee is planned for October 2014. According to WHO, the rationale behind the revision of this guideline is to further support the scope of process validation linked to quality risk management and quality by design principles as described by the ICH and the WHO itself.

This guideline is applicable for different approaches in process validation and mainly applicable to non-sterile finished pharmaceutical dosage forms. Similar approaches may be appropriate for APIs and sterile products, too. The main focus is on the life-cycle approach which links product and process development, validation of the commercial manufacturing process and maintaining the process in a state of control during routine commercial production. A risk-based approach in validation is recommended along with the use of in-line, online and/or at-line controls and monitoring.

The document consists of 16 pages and is structured into 7 chapters:

• Background and scope
• Glossary
• Introduction
• Process qualification
• Continued process verification
• Change control
• References