The Promoting the Quality of Medicines (PQM) program helps pharmaceutical manufacturers comply with international quality standards.
Shortages in quality-assured medicines undermine the global fight against tuberculosis, malaria, HIV/AIDS, and other health challenges. Investments that build local capacity to manufacture medicines according to international quality standards and bring low-cost, locally-produced medicines to markets faster are urgently needed to achieve universal health coverage goals.
PQM collaborates with the World Health Organization (WHO) and other United Nations agencies to build capacity of local manufacturers that produce essential medicines or the active ingredients and wish to expand to local, regional, or global markets. The program provides technical support to enable manufacturers to comply with international standards for Good Manufacturing Practices. This helps companies build stronger quality-assurance systems and satisfy regulatory requirements for marketing authorization and procurement.
This approach makes it easier for:
- Local manufacturers to obtain WHO prequalification or approval from Stringent Regulatory Authorities (SRA) and local regulatory authorities.
- Contract research organizations to comply with international standards for Good Clinical Practices and Good Laboratory Practices.
Areas of Technical Support & Training
- Active pharmaceutical ingredient and product development
- Technology transfer
- Process scale up
- Dossier compilation
- Good Manufacturing Practices
- WHO prequalification and SRA approval