A review on process validation
Journal Title: International Journal of Pharmaceutical and Medicinal Reserach - Year 2014, Vol 2, Issue 3
Abstract
The present article gives an introduction and general overview on process validation of pharmaceutical manufacturing process especially tablet manufacturing process. Process validation is an important component in the design, prototyping and manufacturing process and assures that a process will consistently produce product, meeting its predetermined quality characteristics and attributes. As quality is always an imperative prerequisite when we consider any product therefore, drugs must be manufactured to the highest quality levels. Also end-product testing by itself does not guarantee the quality of the product so quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. In pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it had proven to be an important tool for quality management of pharmaceuticals.
Authors and Affiliations
Rupinder Singh, Ujjwal Nautiyal, Senthil Kumar,Chandra kant
Keywords
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