WHO: Appendix 7: Non-sterile Process Validation - GMP Publishing

WHO: Appendix 7: Non-sterile Process Validation

This month, the WHO has published a proposal for the revision of the supplementary guidelines on GMP: Validation, namely Appendix 7 – non-sterile process validation. A presentation to the WHO Expert Committee is planned for October 2014.

 

According to the WHO, the reason for this revised version 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.

The guideline allows for different approaches in process validation and is mainly applicable to non-sterile finished pharmaceutical dosage forms. Similar approaches may be appropriate for APIs and sterile products, too. The focus is clearly set 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

If you are interested in the proposal for the revision of Annex 7, please click here.

source:

http://www.gmp-publishing.com/en/gmp-news/gmp-aktuell/who-non-sterile-process-validation-appendix-7.html