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 materials 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 authorized and on the market, aim 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.
Ce document est 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 aussi apply to active substances. HOWEVER, information on validation of non-sterile active substances is not required in the case. In addition, expectations for active substances are contained in ICH Q11 and so the information is not repeated in this document.