UGC Approved Journal no 63975(19)
New UGC Peer-Reviewed Rules

ISSN: 2349-5162 | ESTD Year : 2014
Volume 12 | Issue 12 | December 2025

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Volume 12 Issue 12
December-2025
eISSN: 2349-5162

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Published Paper ID:
JETIR2512354


Registration ID:
573242

Page Number

d419-d433

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Title

Quality Control And Quality Assurance: Pillars Of Pharmaceutical Product Integrity

Abstract

Quality Control and Quality Assurance are foundational to pharmaceutical safety, efficacy, and regulatory compliance. This comprehensive review examines how QC and QA systems ensure drug product quality through analytical testing, process monitoring, and regulatory adherence. Modern pharmaceutical quality assurance integrates sophisticated analytical methodologies including High-Performance Liquid Chromatography, mass spectrometry, and spectroscopic techniques with statistical process control and emerging technologies such as Process Analytical Technology and Real-Time Release Testing. International harmonization through ICH guidelines and pharmacopeial standards (USP, BP, IP, EP) provides globally recognized quality frameworks. Advanced technologies including artificial intelligence, blockchain, and automation represent future directions for quality assurance innovation. This project synthesizes current knowledge and emerging trends in pharmaceutical QC and QA, emphasizing their essential role in protecting patient health and maintaining product integrity. Understanding these quality systems is imperative for pharmacy professionals operating in contemporary pharmaceutical manufacturing environments where regulatory expectations and product complexity continue to escalate.

Key Words

Quality Control, Quality Assurance, Analytical Method Validation, Process Analytical Technology, Statistical Process Control.

Cite This Article

"Quality Control And Quality Assurance: Pillars Of Pharmaceutical Product Integrity", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.12, Issue 12, page no.d419-d433, December-2025, Available :http://www.jetir.org/papers/JETIR2512354.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

"Quality Control And Quality Assurance: Pillars Of Pharmaceutical Product Integrity", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.12, Issue 12, page no. ppd419-d433, December-2025, Available at : http://www.jetir.org/papers/JETIR2512354.pdf

Publication Details

Published Paper ID: JETIR2512354
Registration ID: 573242
Published In: Volume 12 | Issue 12 | Year December-2025
DOI (Digital Object Identifier):
Page No: d419-d433
Country: Pune, Maharashtra, India .
Area: Pharmacy
ISSN Number: 2349-5162
Publisher: IJ Publication


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