Pharmaceuticals process validation committee

The reader may wonder why process validation is included. This is simply a matter of consideration of the content of guidelines issued in the past that relate to development pharmaceutics. The first such pan-European guideline, adopted by the Committee for Proprietary Medicinal Products (CPMP) in 1988, included advice on both development pharmaceutics and process development. Later versions of the guidelines on development pharmaceutics and on process development have addressed these topics separately, but the historical and practical perspectives suggests that both need to be discussed here. 

This procedure provides the information required to support the sterility assurance of the drug product (product name), USP, manufactured by ABC Pharmaceutical Industries. It references the FDA Guidance titled Guidance for Industry for the Submission of Documentation for Sterilization Process Validation in Applications for Human and Veterinary Dmg Products prepared by the Sterility Technical Committee of the Chemistry Manufacturing Controls Coordinating Committee of the Center for Dmg Evaluation and Research (CDER) and the Center for Veterinary Medicine (CVM) in November of 1994. 

PhARMA QC Section, Bulk Pharmaceuticals Committee. Concepts for the process validation of bulk pharmaceutical chemicals. Pharm Tech Eur 6(l) 37-42 (Jan. 1994). 

Institute of Validation Technology Standards Committee. Proposed validation standard VS-1-nonaseptic pharmaceutical processes. J Val Tech 6(2) (Feb. 2000). 

WHO expert committee on specifications for pharmaceutical preparations, 34th report. Good Manufacturing Practices Guidelines on Validation of Manufacturing Processes (Annex 6). Geneva World Health Organization, 1996. 

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