Volume : 12, Issue : 01, January – 2025
Title:
ROLE OF QUALITY MANAGEMENT SYSTEM (QMS) FOR EFFECTIVE REGULATORY COMPLIANCE
Authors :
Bodige Sai Prasanna*, Dr.K. Nagasree, Dr.V. Umarani, Dr.K. Shravankumar
Abstract :
Present day the biggest challenge faced by the pharmaceutical manufacturers is experiencing inspectional Food and Drug administration (FDA) 483’s, warning letters, import alerts and notice of violations from the regulatory authorities. The USFDA’s inspectional outcome has uncovered the retesting of drug ingredients that had failed quality testing, failure to establish corrective and preventive action following an investigation, procedural lapses etc. All these regulatory non-compliances triggered the FDA to issue warning letters, with holding of the product approval or plant shut-down because the US regulator has perceived violations to be of serious significance. Most experts warn that quality systems should focus on sustainability issues and assume that quality problems and regulatory non-compliances will be reduced as a result of the organized way of thinking, transparency, documentation and continuous evaluation of Quality Management System (QMS). QMS is a set of coordinated activities to direct and control an organization in order to continually improve the effectiveness and efficiency of its performance. It is designed and implemented to emphasize continuous improvement for state of compliance. QMS starts with recognizing that customers play a significant role in defining requirements as inputs and monitoring of customer satisfaction is necessary to evaluate and validate whether customer requirements have been met. QMS also lives in a dynamic regulatory environment of the registration and compliance requirements of global markets as well as inspections. As QMS is related to regulatory compliance and continuous inspection readiness, it shall maximize benefit to the organization by improving quality, increasing the yield, cutting costs and finally curbing FDA 483’s, warning letters and import alerts. The article details about the significance of QMS and its modules for effective regulatory compliance.
Keywords: Inspectional FDA 483’s, warning letters, CAPA, QMS.
Cite This Article:
Please cite this article in press Bodige Sai Prasanna et al., Role Of Quality Management System (QMS) For Effective Regulatory Compliance .,Indo Am. J. P. Sci, 2025; 12 (01).
Number of Downloads : 10
References:
1. ICH Q7a: “Good Manufacturing Practice (GMP) Guide for Active Pharmaceutical Ingredients (APIs)”, published November 2000
2. EN ISO 9001: 2000 “Quality Management Systems – Requirements”, published December 2000
3. EN ISO 9004: 2000 “Quality Management Systems – Guidelines for performance improvements”, published December 2000
4. EN ISO 9000: 2000 “Quality Management Systems – Fundamentals and vocabulary”, published December 2000
5. ISO 9000: “Introduction and support package; Guidance on the concept and use of the process approach for management systems” – document: ISO/TC 176/SC 2/N544R2, published 13 May 2004
6. CEFIC: “ISO 9001: 2000 CEFIC Guidelines for use by the chemical industry”, published March 2001
7. APIC/CEFIC: “How to do – an interpretation of ICH Q7a”, published 2002
8. APIC/CEFIC: Quality Management System for Active Pharmaceutical Ingredients Manufacturers – integrating GMP into ISO 9001: 1994, published 1998
9. ANSI/ISO/ASQ Q9001:2008 Quality Management Systems ‐ Requirements, American Society for Quality, 2008.
10. AS9100 Rev C Aerospace Quality Management System Standard, IAQG, 2009
11. URL:http://www.mastercontrol.com/quality-management-software/integrated-quality-management-system.html
12. ICH1 Guidance E6: Good Clinical Practice: Consolidated guideline (and see Clinical Quality Management System)
13. Pyzdek, T, “Quality Engineering Handbook”, 2003, ISBN 0-8247-4614-7
14. Juran, Joseph M. and De Feo, Joseph A., “Juran’s Quality Handbook”, 6th Edition, 1999, ISBN 978-0-07-162973-7
15. ICH Harmonized Tripartite Guideline. Guideline for Good Clinical Practice [E6 (R1)] Current step 4 version (including the post step 4 correction): http://www.ich.org [last dated on 1996 June 10].