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An overview : validation and its implication in pharmaceutical industry

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Validation and its implication in pharmaceutical industry_Rashid HA_IJIPS_2014.pdf (416.8Kb)
Date
2014
Author
Rashid, Harun Ar
Sadik Faisal, Khandokar
Sheresta, Rajendra
Kawsar, Md. Abu
Saha, Mithun
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Abstract
In this review article, it has been tried to focus on familiarizing ideas of validation, its types and applications in different sectors of pharmaceutical industry. It has also been tried to integrate the information why and how validation has become integral and inseparable part of GMPs. Quality, identity, purity, stability, strength, safety and efficacy of the drug product are prime requirement of GMPs and cGMPs. These are the parameters that every drug should satisfy to ensure that they are consistently produced and controlled to quality standards, appropriate to their intended use as required by the product specification. Validation is the action of proving effectiveness by means of proper documentation, and accomplished through proper implementation of norms of GMP and cGMPs through mutual collaboration of each individuals involved in the manufacturing of medicinal products following a set of protocols. In order to build up quality in products, every pharmaceutical industry should put their prime focus in validation.
URI
http://hdl.handle.net/123456789/611
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