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INTERNATIONAL JOURNAL OF CREATIVE RESEARCH THOUGHTS - IJCRT (IJCRT.ORG)
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ISSN Approved Journal No: 2320-2882 | Impact factor: 7.97 | ESTD Year: 2013
Call For Paper - Volume 12 | Issue 5 | Month- May 2024
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Paper Title
REVIEW ARTICLE ON VALIDATION AS QUALITY ASSURANCES TOOL
Authors
Shital Raju khot, Rohini Shivprasad Khobare
Keywords
Quality assurance, Process validation, GMP, pharmaceutical industry.
Abstract
Validation is the most recognized and important parameter of GMPs. This article provides an introduction about the process validation of the pharmaceutical manufacturing process and its importance according to The U.S. Food and Drug Administration (FDA). This work is to present an introduction and general overview on process validation of the pharmaceutical manufacturing process. Quality cannot be ensured by sampling, testing, release of materials and products. Quality assurance techniques must be used to build the quality into the product at every step and not just tested for at the end. Process validation of a process will ensure production of a drug of reproducible quality. In the pharmaceutical industry, Process Validation performs this task to build the quality into the product because according to ISO 9000:2000, it has proven to be an important tool for quality management of pharmaceuticals.
IJCRT's Publication Details
Unique Identification Number - IJCRT2107425
Paper ID - 210075
Page Number(s) - e23-e39
Pubished in - Volume 9 | Issue 7 | July 2021
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Publisher Name - IJCRT | www.ijcrt.org | ISSN : 2320-2882
E-ISSN Number - 2320-2882
Cite this article
Shital Raju khot, Rohini Shivprasad Khobare, "REVIEW ARTICLE ON VALIDATION AS QUALITY ASSURANCES TOOL", International Journal of Creative Research Thoughts (IJCRT), ISSN:2320-2882, Volume.9, Issue 7, pp.e23-e39, July 2021, Available at :http://www.ijcrt.org/papers/IJCRT2107425.pdf
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ISSN: 2320-2882 Impact Factor: 7.97 and ISSN APPROVED Journal Starting Year (ESTD) : 2013
ISSN and 7.97 Impact Factor Details
ISSN: 2320-2882 Impact Factor: 7.97 and ISSN APPROVED Journal Starting Year (ESTD) : 2013
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