UGC Approved Journal no 63975(19)

ISSN: 2349-5162 | ESTD Year : 2014
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Published in:

Volume 10 Issue 2
February-2023
eISSN: 2349-5162

UGC and ISSN approved 7.95 impact factor UGC Approved Journal no 63975

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Published Paper ID:
JETIR2302436


Registration ID:
508903

Page Number

e302-e310

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Title

A REVIEW ON PROCESS VALIDATION OF SOLID DOSAGE FORM (CAPSULE)

Abstract

Every time a product is taken into consideration, quality is an absolute requirement. Drug production must therefore be of the greatest caliber. A productive production process is essential for incorporating quality into the goods, and validation is a component of the quality assurance programme. Process validation is the validation of a process's constituent steps. Validating a process is gathering and analyzing data from the process design stage through production to generate scientific proof that a method is able to reliably produce a high-quality medicinal material. The validation's aim is to make sure that quality is incorporated throughout the system rather than merely evaluated for at the end. It entails the gathering and assessment of data that establishes scientific proof that a process is capable of reliably producing a high-quality pharmacological ingredient, starting with the process design stage and continuing through production. According to cGMP, process validation is a crucial component of quality assurance. Together, validation and quality control will guarantee the items' thorough quality. As a result, emphasis is placed on reviews that provide a thorough summary of validation.Validation studies must be carried out in accordance with established methods, as per GMP. Different validation procedures apply to various dose types. With particular reference to the requirements set forth by the US Food and Drug Administration (FDA) for Solids (capsules), Liquids, and Semisolids, the work's goal is to give an introduction and basic overview on process validation of pharmaceutical manufacturing process.

Key Words

Quality; Validation; Dosages form; CGMP

Cite This Article

"A REVIEW ON PROCESS VALIDATION OF SOLID DOSAGE FORM (CAPSULE)", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.10, Issue 2, page no.e302-e310, February-2023, Available :http://www.jetir.org/papers/JETIR2302436.pdf

ISSN


2349-5162 | Impact Factor 7.95 Calculate by Google Scholar

An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 7.95 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator

Cite This Article

"A REVIEW ON PROCESS VALIDATION OF SOLID DOSAGE FORM (CAPSULE)", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.10, Issue 2, page no. ppe302-e310, February-2023, Available at : http://www.jetir.org/papers/JETIR2302436.pdf

Publication Details

Published Paper ID: JETIR2302436
Registration ID: 508903
Published In: Volume 10 | Issue 2 | Year February-2023
DOI (Digital Object Identifier):
Page No: e302-e310
Country: -, -, India .
Area: Engineering
ISSN Number: 2349-5162
Publisher: IJ Publication


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