Good Manufacturing Practices Assessment and Discussions on WHO Prequalification

The purpose of the trip was to conduct a Good Manufacturing Practices (GMP) assessment of zinc sulfate manufacturing activities at Cosmos Ltd. and provide technical assistance on GMP compliance. Additionally, the trip included a visit to Sky Light Chemicals Ltd. to discuss future collaboration for products to be submitted to WHO Prequalification (PQ) for second-line tuberculosis (TB) drugs. The assessment at Cosmos Ltd. was conducted using the World Health Organization (WHO) inspection procedures approach for auditing the manufacture of pharmaceuticals. The assessment revealed that the firm has the systems in place as well as the capabilities, facilities, infrastructure, knowledge, and skills necessary to manufacture zinc finished pharmaceutical products (FPP) compliant with WHO GMP. The non-compliances and opportunities for improvement observed during the assessment are listed in a full confidential report for the manufacturer. The meeting with Sky Light Chemicals Ltd. discussed the technical assistance that PQM can offer the firm in the process of obtaining WHO prequalification for second-line TB medicines. Sky Light manufactures pharmaceutical liquid formulations and plans to expand to manufacture creams, ointments, tablets, and capsules in the next year. The company is interested in receiving PQM technical assistance for second-line TB products next year, after the construction is complete and the new manufacturing facility is commissioned. The trip was funded by USAID through Core Maternal and Child Health (MCH) and Core TB. The assessment at Cosmos Ltd. was successful, with Cosmos and PQM planning to work together to implement a Corrective and Preventive Action (CAPA) plan and compile the zinc sulfate dossier for submission. Discussions regarding PQM technical assistance for second-line TB medicines with Sky Light were also fruitful. The assessment at Cosmos Ltd. covered the areas listed in the table below, including utilities, manufacturing areas, warehouse, and quality control/microbiology laboratories. The key findings of the visit were presented to key Cosmos personnel on the final day, and a complete confidential report of the visit observations, findings, and recommendations will be sent to the company separately. Cosmos has the required systems to successfully participate in the WHO PQ Program for zinc sulfate tablets. The next steps include Cosmos compiling the zinc sulfate dossier by September 2012 and PQM supporting Cosmos on GMP corrective and preventive action plan implementation. The trip report highlights the importance of Good Manufacturing Practices in ensuring the quality and safety of medicines. The assessment at Cosmos Ltd. and the discussions with Sky Light Chemicals Ltd. demonstrate the commitment of PQM to providing technical assistance to developing countries to build local capacity in medicine quality assurance systems and increase the supply of quality medicines to priority USAID health programs.