Promoting the Quality of Medicines

PQM works with manufacturers interested in improving their quality systems to produce medicines that meet requirements of the World Health Organization (WHO) Prequalification Programme. PQM guides manufacturers through the complex process and prepares them for WHO audits of documentation and facilities. The initiative focuses on quality system development, validation master plan, and GMP compliance level assessments. PQM staff perform an initial evaluation of qualifying companies to determine their level of compliance with critical GMP elements. PQM has successfully provided technical assistance to manufacturers of zinc sulfate and anti-tuberculosis (TB) medicines. The initiative helped manufacturers strengthen their quality assurance systems and compliance to meet international GMP standards. To date, one manufacturer has reached WHO Prequalification for zinc formulations, two others are one step away, and five more are making progress toward that goal. PQM is assisting 21 manufacturers of TB medicines in nine countries to achieve WHO Prequalification. The technical assistance provided by PQM is instrumental in their journey to reach WHO Prequalification. The demand for WHO-prequalified products by procurement agencies and PQM's technical assistance to manufacturers are increasing the availability of quality-assured medicines. Achieving compliance with WHO GMP standards presents manufacturers with an exceptional opportunity and an optimistic future. They will have access to additional markets, bringing increased revenue that can be reinvested in quality systems and also advance sustained production of quality-assured pharmaceuticals.