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Guidelines on good manufacturing practices: validation,
Appendix 7: non‑sterile process validation
Background:
The appendices of the Supplementary guidelines on good manufacturing practices:
validation currently comprise the following:
Appendix 1. Validation of heating, ventilation and air-conditioning systems
Appendix 2. Validation of water systems for pharmaceutical use
Appendix 3. Cleaning validation
Appendix 4. Analytical method validation
Appendix 5. Validation of computerized systems
Appendix 6. Qualification of systems and equipment
Appendix 7. Non-sterile process validation – revised text reproduced in this Annex
1. Background and scope:
Further to the Supplementary guidelines on good manufacturing practices: validation, as published in the World Health Organization (WHO) Technical Report Series, No. 937 (1), additional guidelines to support current approaches to good manufacturing practices (GMP) are published here. These guidelines are intended to further support the concept of process validation linked to quality risk management (QRM) and quality by design principles as described by WHO and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
These guidelines allow for different approaches to process validation. The principles described are mainly applicable to non-sterile finished pharmaceutical dosage forms. Similar approaches may be applicable to active pharmaceutical ingredients (APIs) and sterile products. (See also recommendations in WHO Technical Report Series, No. 957, Annex 2 (2) and WHO Technical Report Series, No. 961, Annex 6 (3).)
A risk-based and life-cycle approach to validation is recommended.
Thorough knowledge of product and process development studies; previous manufacturing experience; and QRM principles are essential in all approaches to process validation, as the focus is now on the life cycle approach. The life-cycle approach links product and process development, validation of the commercial manufacturing process and maintaining the process in a state of control during routine commercial production.
The use of process analytical technology (PAT), which may include in‑line, online and/or at-line controls and monitoring, is recommended to ensure that a process is in a state of control during manufacture.
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WHO TRS (Technical Report Series) 992, 2015 Annex 3:
