QUALITY MANAGEMENT SYSTEM (QMS) IN PHARMACEUTICALS

Quality Management System (QMS) is an essential framework in the pharmaceutical industry to ensure that the medicinal products are consistently manufactured and controlled according to quality standards. A robust QMS integrates organizational structure, procedures, processes, and resources to achieve quality objectives and regulatory compliance. This review article discusses the concept of QMS, its elements, objectives, regulatory guidelines and implementation in pharmaceutical industries, and its role is ensuring the product quality, safety, and efficacy. The importance of QMS in maintaining the compliance with Good Manufacturing Practices (GMP) and the international regulatory requirements is also highlighted.

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-12-30
DOI
https://doi.org/10.5281/zenodo.18097981
Primary Topic
Pharmaceutical Quality and Counterfeiting
Type
article
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article

QUALITY MANAGEMENT SYSTEM (QMS) IN PHARMACEUTICALS

*Ms. Narmatha Rajeswari
Zenodo (CERN European Organization for Nuclear Research)
Pharmaceutical Quality and Counterfeiting
article

QUALITY MANAGEMENT SYSTEM (QMS) IN PHARMACEUTICALS

*Ms. Narmatha Rajeswari
article en

Abstract

Quality Management System (QMS) is an essential framework in the pharmaceutical industry to ensure that the medicinal products are consistently manufactured and controlled according to quality standards. A robust QMS integrates organizational structure, procedures, processes, and resources to achieve quality objectives and regulatory compliance. This review article discusses the concept of QMS, its elements, objectives, regulatory guidelines and implementation in pharmaceutical industries, and its role is ensuring the product quality, safety, and efficacy. The importance of QMS in maintaining the compliance with Good Manufacturing Practices (GMP) and the international regulatory requirements is also highlighted.

Zenodo (CERN European Organization for Nuclear Research)
Industry, innovation and infrastructure
Openalex Percentile: Top 25%
Pharmaceutical Quality and Counterfeiting
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