Decoding WHO API Prequalification: A Guide for Manufacturers and Buyers
Description: The World Health Organization’s API Prequalification (API PQ) program is a globally recognized mechanism that ensures the quality, safety, and consistency of Active Pharmaceutical Ingredients (APIs) used in essential medicines. It evaluates both the API and its manufacturing site(s) to verify compliance with WHO Good Manufacturing Practices (GMP) and international quality standards. This process offers transparency for global buyers, dossier teams, and manufacturers — helping the pharmaceutical supply chain maintain quality and reliability across markets.
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