A Review on Step-by-Step Analytical Method Validation
Journal Title: IOSR Journal of Pharmacy (IOSRPHR) - Year 2015, Vol 5, Issue 10
Abstract
When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy which documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis
Authors and Affiliations
Panchumarthy Ravisankar*1 , Ch. Naga Navya1 , D. Pravallika1 , D. Navya Sri 1
Keywords
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