INDUSTRIAL PROCESS VALIDATION OF SOLID ORAL DASAGE FORM: A REVIEW
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2013, Vol 4, Issue 5
Abstract
Validation is the important step in gaining and maintaining the quality of the final product. Validation of the individual steps of the processes is called the process validation. Different dosage forms have different validation protocols. Validation is therefore is one element of quality assurance programs and is associated with a particular process therefore word validation simply means “assessment of validity” or action of proving effectiveness. Validation thus provides a higher degree of assurance that the manufacturing process consistently meets the pre-determined specifications and the quality products output can be used to increase productivity, its consistent quality and decreasing the need for processing and market complaints of the drug product. This overview examines the need for pharmaceutical validation, the various approaches and steps involved.
Authors and Affiliations
Vishal Sharma, A. C. Rana, Nimrata Seth
Keywords
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