PQM helps strengthen regulatory systems and increase the capacity of national quality control laboratories (NQCLs) to detect poor-quality medicines, while also helping improve manufacturers’ ability to produce quality-assured medicines. These documents describe the ways in which we approach our work, detail select accomplishments, and report on key activities:
Strengthening national regulatory systems and increasing laboratory capacity to detect poor-quality medicines
- A Risk-Based Resource Allocation Framework for Pharmaceutical Quality Assurance for Medicines Regulatory Authorities in Low- and Middle-Income Countries (6/2018)
This document proposes a framework to assist medicines regulatory authorities in lower- and middle-income countries in managing and sustainably supporting pharmaceutical quality assurance to achieve maximum health impact and efficiencies. The framework is specifically intended as a guide for the development of country-specific resource allocation tools, and consists of six core elements: (1) risk analysis, (2) analysis of the pharmaceutical market, (3) analysis of country characteristics, (4) assessment of the regulatory and quality assurance environment, (5) risk management, and (6) assessment of the impact of resource allocation.
- Guidance for Implementing Risk-Based Post-Marketing Quality Surveillance in Low- and Middle-Income Countries (2/2018)
Strong national post-marketing surveillance programs capable of monitoring the overall quality of medical products (e.g., medicines, vaccines, devices, and diagnostic kits) and responding to public health risks can help protect populations from the threats posed by substandard and falsified medicines. The PQM program, through extensive consultation with international experts, has developed this document to guide the implementation of comprehensive risk-based post-marketing surveillance programs in low- and middle-income countries.
- Strengthening National Quality Control Laboratories in Low- and Middle-Income Countries to Improve the Quality of Medicines (2/2018)
The document describes PQM’s technical approach to building the managerial and technical capabilities of national quality control laboratories to strengthen local capacity to detect substandard and falsified medicines. This approach has guided PQM in supporting national quality control laboratories to develop stronger laboratory quality management systems, comprehensive laboratory quality assurance policies and practices, medium- and long-term instrument maintenance plans, and risk-based sampling and testing activities.
- Analytical Instrumentation Support for National Quality Control Laboratories (2/2018)
This document outlines PQM’s approach to supporting national quality control laboratories in managing and maintaining their analytical instrumentation and outlines strategies for building in-house expertise of laboratory staff, strengthening the capacity of national metrology institutes, and strategically partnering with contract service providers to share resources and calibration reference standards.
- Strengthening national capacity in medicines quality: five-year summary 2005–2009, Promoting the Quality of Medicines program in Southeast Asia and the Philippines (3/2010)
- Ensuring the quality of medicines in resource-limited countries: an operational guide (2007)
Increase the supply of quality-assured medicines
- Revisiting the Stability and Storage Specifications of Oxytocin Injection: A Literature Review (7/2018)
- Strengthening Manufacturing Capacity to Improve Access to Quality-Assured Essential Medicines (12/2017)
PQM works to strengthen the capacity of pharmaceutical manufacturers to produce quality-assured medicines and collaborates with manufacturers globally to address critical shortages or gaps in the supply of essential medicines. This technical report describes the support PQM provides to manufacturers and the technical approach employed.
- Production of zinc tablets and zinc oral solutions: guidelines for programme managers and pharmaceutical manufacturers (2007)
Collection and utilization of medical product quality information to increase evidence-based decision-making
- The state of medicine quality in the Mekong sub-region (11/2014)
- Post-market quality surveillance project: maternal healthcare products (oxytocin and ergometrine) (2/2013)
- Impact of educational programs on prescribing patterns of antimicrobial medicines in multidisciplinary hospitals in different regions of Russia (1/2010)
- Survey of the quality of selected antimalarial medicines circulating in Madagascar, Senegal, and Uganda (QAMSA – 11/2009)