Pharma Science Monitor an International Journal of Pharmaceutical Sciences Process Validation in Pharmaceutical Industry: a Review
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چکیده
Validation is a tool of quality assurance which provides confirmation of the quality in equipment system, manufacturing processes, software and testing methods. Validation assures the products with predetermined quality characteristics and attributes can be reproduced consistently/reproducibly with in the established limits of the manufacturing process operation at the manufacturing site. Validation is required in order to move a product from development to commercial production. Different dosage form have different validation protocol. This paper presents an introduction, basic concepts involved in process validation, approaches for process validation and general overview on process validation in pharmaceutical industry.
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Pharma Science Monitor an International Journal of Pharmaceutical Sciences a Review: Chemical Penetration Enhancers
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تاریخ انتشار 2013