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INTERNATIONAL JOURNAL OF SCIENTIFIC DEVELOPMENT AND RESEARCH
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ISSN Approved Journal No: 2455-2631 | Impact factor: 8.15 | ESTD Year: 2016
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Issue: June 2022

Volume 7 | Issue 6

Impact factor: 8.15

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Paper Title: Pharmaceutical Validation and Process Controls Approaches: A Review
Authors Name: Ankush Pralhad Jadhav , Tejashree Radhakisan Kedar , Rushikesh Narayan Jagtap
Unique Id: IJSDR2206011
Published In: Volume 7 Issue 6, June-2022
Abstract: The overall validation study provides us the accuracy, stability, sensitivity and reproducibility of the test methods results based into the documented forms. The validation is an essential part of the quality assurance as well as quality control in organization. This whole process includes not only equipment but also raw material inspections as well as in process controls parameters. Process controls are mandatory to maintain good manufacturing practice i.e. G.M.P. and according to it validation studies are required to be done as per predefined protocols, the minimum that should be validated. Validation is an integral part of quality assurance, it include process, cleaning and testing as a result such control procedure stablish to monitor the output and validation of manufacturing processes that may be responsible for variability of drug product.
Keywords: Major phases in validation, Strategy for the validation of methods, Environmental considerations- cleaning and clean room standards, Process validation, Validation report.
Cite Article: "Pharmaceutical Validation and Process Controls Approaches: A Review", International Journal of Science & Engineering Development Research (www.ijsdr.org), ISSN:2455-2631, Vol.7, Issue 6, page no.75 - 79, June-2022, Available :http://www.ijsdr.org/papers/IJSDR2206011.pdf
Downloads: 00096793
Publication Details: Published Paper ID: IJSDR2206011
Registration ID:200556
Published In: Volume 7 Issue 6, June-2022
DOI (Digital Object Identifier):
Page No: 75 - 79
Publisher: IJSDR | www.ijsdr.org
ISSN Number: 2455-2631

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