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Scholars Academic Journal of Pharmacy | Volume-10 | Issue-06
An Overview on Validation Process in Pharmaceutical Industries
Swati Sabale, Santosh Thorat
Published: June 15, 2021 |
153
550
DOI: 10.36347/sajp.2021.v10i06.001
Pages: 95-101
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Abstract
Medicinal products are the prime element in the healthcare and must manufacture with the highest quality, safety & efficacy level. There are multiple principles to obtain such quality are now biggest interest in pharmaceutical industry. One of the important principles that industries follow is Validation. It is the art of designing and practicing the designed steps alongside with the documentation for all processes, methods, computer systems, equipment qualification & revalidation. According to GMP validation studies it is the necessary part of GMP and required to be done as per predefined protocols. Validation master plan (VMP) defines the principles involved in the qualification of a facility, describes the systems to be validated, and provides a updated plan for accomplishing and keeping a qualified facility. The VMP is quite different than validation procedure (SOP), which explains the specific process for performing validation activities.