RE: Process Validation Contribution from Mike Edgington written on 10/8/2004 at 15:26
Original contribution: Process Validation written by Dr. Sirsendu Sukul on 10/4/2004 at 11:20) Dear Dr.Sukul,
With respect to your first point I refer you to the following document on process validation CPMP/QWP/848/96
EMEA/CVMP/598/99 and Annex II of the document. This will outline for you the requirements for process validation for a pharmaceutical product.
The answer to your second point is no. Microbiological validations should as a minimum be performed as outlined in the pharmacopeial texts/ USP <1227> or Ph. Eur. It is a USP requirement that the validation is performed in triplicate. As a matter of good practice positive and negative controls should be included.
Answering this Contribution:
|
