All you need to know about Process Validation: A course for Process and Production Chemists
Event Date/Time: Nov 23, 2005
End Date/Time: Nov 25, 2005
For anyone who wishes to put a pharma product on the US market GMP regulations (21 CFR part 210 & 211) require validation of the process. This applies to finished pharma products but the principles of cGMP are applicable to APIs (Active Pharmaceutical Ingredients) as defined in FD&C act, hence API manufacturing processes require validation. Basically, what validation is doing, is ensuring that you have a stable process that can consistently produce product meeting specification.