Biopharmaceutics process validation is the most important and recognized parameters of CGMPs.The requirement of process validation appears of the quality system (QS) regulation. The goal of a quality system is to consistently produce products that are fit for their intended use. Process validation is a key element in assuring that these principles and goal are met. The process validation is standardization of the validation documents that must be submitted with the submission file for marketing authorization
Journals related to Biopharmaceuticals process validation
Drug Designing: Open Access, Advances in Pharmacoepidemiology & Drug Safety, Journal of Drug Metabolism & Toxicology, Clinical Pharmacology & Biopharmaceutics, Process Validation for Biopharmaceuticals, Validation of Biopharmaceutical Manufacturing Processes, Drug Development and Industrial Pharmacy, Pharmacogenomics & Pharmacoproteomics, International Journal of Pharmaceutical Sciences and Research, Journal of Advanced Pharmaceutical Technology & Research.
Biopharmaceuticals Process Validation