Harmonizing Quality Assurance and Quality Control to Enhance Patient Safety and Ensure Regulatory Compliance in Pharmaceuticals
Year: 2025
Type: article
Abstract: The Quality Assurance (QA) and Quality Control (QC) units play a vital role in maintaining the consistency, safety, and effectiveness of pharmaceutical products.QA adopts a preventive and organized strategy, emphasizing the establishment of standard operating procedures, periodic audits, workforce training, and compliance with regulatory requirements, while focusing on the 5Ms-Man, Material, Machinery, Method, and Motivation.In contrast, QC serves as a detective and corrective mechanism, concentrating on identifying errors, performing systematic testing, maintaining documentation, and verifying compliance throughout the manufacturing process.Together, QA and QC safeguard patient well-being, uphold international regulatory standards, boost operational efficiency, and strengthen industry credibility by ensuring data integrity and promoting global trust in pharmaceutical products.
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W4413646120