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Pharmaceutical Process Validation: A Key Requirement for Quality Attribute Kulkarni Sukhada*, Panda Amrita, Tiwari Ravi Department of Pharmaceutical Chemistry, SVKM's NMIMS, School of Pharmacy and Technology Management Shirpur, Dist. Dhule-425405, Maharashtra, India *Corresponding Author E-mail: sukhadakulkarni26@gmail.com
Online published on 27 March, 2014. Abstract The rationale of this article is to present a preface and general idea on process validation of pharmaceutical manufacturing process. In order to achieve the highest quality of a manufactured drug, process validation is regarded as crucial step in achieving and maintaining the quality of the final product. Quality techniques must be built into the product at every step and not just tested for final product. Thus regulatory gives certain specific guidelines to focus on strict quality control. Top Keywords Process Validation, Regulatory Guidelines, Quality Control. Top | |
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