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International Journal for Research Trends and Innovation
International Peer Reviewed & Refereed Journals, Open Access Journal
ISSN Approved Journal No: 2456-3315 | Impact factor: 8.14 | ESTD Year: 2016
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Issue: December 2025
Volume 10 | Issue 12
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Impact Factor : 8.14
Issue per Year : 12
Volume Published : 10
Issue Published : 115
Article Submitted : 19440
Article Published : 8041
Total Authors : 21252
Total Reviewer : 769
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| Paper Title: | A Review on Pharmaceutical Process Validation |
| Authors Name: | Pratiksha S. Shinde , Tejashri R. Kedar , Unnati N. Shetiya , Aarti J. Shete |
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| Author Reg. ID: |
IJRTI_188685
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| Published Paper Id: | IJRTI2312046 |
| Published In: | Volume 8 Issue 12, December-2023 |
| DOI: | |
| Abstract: | Process validation is a continuous process that ensures consistent, high-quality outputs from various inputs. It is crucial for developing a reliable manufacturing process for producing drugs with minimal fluctuations, ensuring purity, identification, and potency. The process Development Designee reviews the Product Development Report, data from the pilot scale, scale-up batch, and suggested master formula for a manufactured product, and ensures the transfer report’s accessibility to the plant and facility’s readiness for validation testing. The designee also creates commercial or exhibit batch production, validating processes after facility, utility, equipment, laboratory tests, raw materials, and packaging specifications. Process validation involves requalification, calibration, verification, maintenance of equipment, setting performance requirements, selecting procedures, tools, and strategies, evaluating the finished product, and scrutinizing, auditing, or sampling crucial stages. The legal foundation for process validation dates back to the early 1970s and is applied to various aspects of manufacturing. |
| Keywords: | Input result, finished product, high quality output, process validation, performance qualification,OQ,DQ, PQ, IQ, qualification, designee, crucial aspects, Quality assurance, quality control, pre-emptive process, analytical method. |
| Cite Article: | "A Review on Pharmaceutical Process Validation", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.8, Issue 12, page no.327 - 338, December-2023, Available :http://www.ijrti.org/papers/IJRTI2312046.pdf |
| Downloads: | 000205331 |
| ISSN: |
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016 An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator |
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Published Paper ID: IJRTI2312046
Registration ID:188685
Published In: Volume 8 Issue 12, December-2023
DOI (Digital Object Identifier):
Page No: 327 - 338 Country: Ahmednagar , Maharashtra , India Research Area: Pharmacy Publisher : IJ Publication Published Paper URL : https://www.ijrti.org/viewpaperforall?paper=IJRTI2312046 Published Paper PDF: https://www.ijrti.org/papers/IJRTI2312046 |
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ISSN: 2456-3315
Impact Factor: 8.14 and ISSN APPROVED,
Journal Starting Year (ESTD) : 2016
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