Abstract

REVIEW ARTICLE: PROCESS VALIDATION USED IN DOSSIERS

M. U. Mishra*, Tina S. Lichade, Chaitanya M. Khandelwal, Parul D. Kawale, Manishkumar L. Bisen, Venu S. Agrawal and Trupti C. Kosarkar

ABSTRACT

The process validation is establishing documented evidence which provides high degree on assurance that a specific process consistently produced a product meeting its predetermined specifications and quality characteristic. According to GMP validation studies are essential part of GMP these are required to be done as per predefined protocols, the minimum that should be validated include process, testing and cleaning as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product. The validation studies provide the accuracy, sensitivity, specificity and reproducibility of the test methods employed by the firms, shall be established and documented. Thus, the validation is an essential part of the quality assurance. The purpose of this work is to present an introduction and general overview on process validation of pharmaceutical manufacturing process especially Bromhexine Syrup manufacturing process with special reference to the requirements stipulated by the US Food and Drug Administration (FDA). Although PVR guidance does not repeat the concepts and Principles explained in PVR guidance’s, FDA encourages the use of modern pharmaceutical development concepts, quality isk management, and quality systems at all stages of the manufacturing process lifecycle. The objective of this protocol is to establish documented evidence that given manufacturing process consistently produces pharmaceutical dosage form of consistent quality, as per predetermine specification. The methods and conclusion of process validation report is documented.

Keywords: Validation, Formatting, Regulatory Affairs, Retrospective Validation, Documented, evidence, et.