WHO GOOD PRACTICES FOR RESEARCH AND DEVELOPMENT FACILITIES OF PHARMACEUTICAL PRODUCTS

ABSTRACT

Background In view of the need for the development of health products, including the research and development for the treatment of COVID-19 therapies, the World Health Organization (WHO) Prequalification Inspection Services Team (PQT INS) raised the urgency for the development of life cycle appropriate good practices text to address the manufacturing of developmental  batches, pilot batches and the sequential stability data that are submitted in product applications (dossiers) for marketing authorization and the prequalification of medical products.