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This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the possibility to use continuous process verification in addition to, or instead of, traditional process validation described in the previous guideline has been added and is encouraged. This guideline does not introduce new requirements on medicinal products already authorised and on the market, but clarifies how companies can take advantage of the new possibilities given when applying enhanced process understanding coupled with risk management tools under an efficient quality system as described by ICH Q8, Q9 and Q10.

This document is intended to provide guidance on the process validation information and data to be provided in regulatory submissions for the finished dosage forms of chemical medicinal products for human and veterinary use. The general principles also apply to active substances. However, information on validation of non-sterile active substances is not required in the dossier. In addition, expectations for active substances are contained in ICH Q11 and so the information is not repeated in this document.

→ Guideline on process validation for finished products - information and data to be provided in regulatory submissions

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L’Association A3P est un acteur incontournable de l’industrie pharmaceutique et biotechnologique. 
Créée en 1986, elle contribue au bon développement de la production de médicaments et de matériels propres et stériles, elle anime un réseau de 21 000 professionnels, fabricants et fournisseurs, dans le cadre de Congrès internationaux et de journées techniques.

Elle regroupe aujourd’hui plus de 1700 adhérents qui partagent leurs expériences techniques, scientifiques et réglementaires.

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