Integrating QA and QC for Patient Safety and Regulatory Compliance in Pharmaceuticals

The Quality Assurance (QA) and Quality Control (QC) divisions are essential in upholding the quality, safety, and reliability of pharmaceutical products. QA takes a proactive and structured approach by formulating standard operating procedures, conducting regular audits, training staff, and ensuring strict adherence to regulatory guidelines, with focus on the 5Ms—Man, Material, Machinery, Method, and Motivation. Conversely, QC functions as a corrective system, aimed at identifying and resolving defects through systematic inspections, testing, documentation, and regulatory compliance checks at different stages of production. Working in tandem, QA and QC protect patient health, ensure compliance with global standards, improve process efficiency, and enhance market credibility by guaranteeing data accuracy and fostering worldwide confidence in pharmaceutical products.

Authors

Publication Details

Journal
International Journal For Multidisciplinary Research
Published
2025-08-27
DOI
https://doi.org/10.36948/ijfmr.2025.v07i04.54490
Primary Topic
Pharmacy and Medical Practices
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

Integrating QA and QC for Patient Safety and Regulatory Compliance in Pharmaceuticals

Shine Sudev, C K Nidha, P Nihala, M Nandana et al.
International Journal For Multidisciplinary Research
Pharmacy and Medical Practices
article

Integrating QA and QC for Patient Safety and Regulatory Compliance in Pharmaceuticals

Shine Sudev, C K Nidha, P Nihala, M Nandana, Nida Musthafa
article en

Abstract

The Quality Assurance (QA) and Quality Control (QC) divisions are essential in upholding the quality, safety, and reliability of pharmaceutical products. QA takes a proactive and structured approach by formulating standard operating procedures, conducting regular audits, training staff, and ensuring strict adherence to regulatory guidelines, with focus on the 5Ms—Man, Material, Machinery, Method, and Motivation. Conversely, QC functions as a corrective system, aimed at identifying and resolving defects through systematic inspections, testing, documentation, and regulatory compliance checks at different stages of production. Working in tandem, QA and QC protect patient health, ensure compliance with global standards, improve process efficiency, and enhance market credibility by guaranteeing data accuracy and fostering worldwide confidence in pharmaceutical products.

International Journal For Multidisciplinary ResearchVol. 7(4)
Openalex Percentile: Top 70%
Pharmacy and Medical Practices
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.