Strengthening Pharmaceutical Quality Control Laboratories: Inspection-Ready Implementation of the World Health Organization Good Practices for Pharmaceutical Quality Control Laboratories and Pathways to Prequalification.

Abstract

Pharmaceutical quality control laboratories are essential to ensuring the safety and quality of medicines. The World Health Organization (WHO) Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL) provide a framework for establishing reliable and inspection-ready laboratory systems. This review critically evaluates the implementation of GPPQCL, examining practical challenges, policy gaps, and variability in adoption across different settings. A structured narrative approach was used to analyze World Health Organization (WHO) guidance, international standards, and relevant literature (2010-2026), with an emphasis on inspection expectations and real-world practices. Effective implementation depends on robust quality management systems, validated methods, competent personnel, and strong data integrity practices. However, challenges such as infrastructure limitations, method standardization, and uneven data governance persist, particularly in resource-limited environments. Evidence from WHO-prequalified laboratories shows that risk-based implementation and capacity-building initiatives can support compliance and international recognition. Overall, GPPQCL provides a practical framework for strengthening laboratory systems, enhancing regulatory confidence, and supporting global efforts to ensure the quality of medicines.