Emerging Trends and Best Practices in Pharmaceutical Quality Assurance and Quality Control: A Comprehensive Review

Authors

  • Sujit Arun Desai
  • Sagar Shinde
  • Aishwarya Bhange
  • Pankaj Ramdas Khuspe

Keywords:

Auditing, GMP, HACCP, ICH Q10, ISO guidelines, NABL, Pharmaceutical quality assurance, Pharmaceutical quality system, Quality control, SOPs, Validation

Abstract

In order to guarantee the safety, effectiveness, and quality of pharmaceutical products, pharmaceutical Quality Assurance (QA) and Quality Control (QC) are crucial steps in the research and production of new drugs. In addition to discussing new developments in QA/QC, this overview covers the fundamentals of the field. Topics covered include the function of the National Accreditation Board for Testing and Calibration Laboratories (NABL), ISO standards, Good Manufacturing Practice (GMP), and harmonized regulatory guidelines like ICH Q10. It also covers validation procedures, the development of Standard Operating Procedures (SOPs), the application of Hazard Analysis Critical Control Point (HACCP) in pharmaceutical settings, and contemporary auditing techniques. Technology integrations such as real-time data monitoring, digital quality management systems and AI-powered validation tools are also covered in the study. These revelations offer a road map for guaranteeing strong pharmaceutical quality systems that meet international regulatory standards.

Published

2025-05-19