WHO invites manufacturers of selected APIs to submit Expressions of Interest (EOIs) for API evaluation and says the ultimate aim of the invitation is to increase the range and availability of particular APIs found to meet WHO-recommended quality standards. This year’s list of APIs features one addition: the anti-tuberculosis drug gatifloxacin.
The APIs and manufacturing sites found to meet the quality standards recommended by WHO will be included in a published list of acceptable APIs for use in the production of finished pharmaceutical products (FPPs), though WHO notes that it remains the ultimate responsibility of the manufacturer of the FPP to ensure the quality of each API.
Quality Assessment
WHO’s assessment of APIs will include the evaluation of API master files (APIMFs), which must include the data and information as specified in guidelines (detailed information on the technical content can be found here), and if acceptable, the API will be included in a list of those considered by WHO to be acceptable for incorporation into finished pharmaceutical products.
“APIs for which an APIMF has already been assessed and accepted by WHO, and the relevant manufacturing site(s) has(have) been inspected by WHO or a Stringent Regulatory Authority in the previous three years and found to comply with WHO GMP requirements for the manufacture of the particular API, may be included in the list without prior reassessment or re-inspection,” the invitation says.
WHO says a “Stringent Regulatory Authority” is: A regulatory authority in a country which is (a) an ICH member (EU, Japan and US); or (b) an ICH Observer (Swiss Medic and Health Canada); or (c) a regulatory authority associated with an ICH member through a legally binding mutual recognition agreement, which includes Australia, Norway, Iceland and Liechtenstein; and a regulatory authority that is a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).
The quality assessment is based on:
● a general understanding of the production and quality control activities of the API manufacturer.
● assessment of API data and information submitted by the manufacturer, which includes the manufacturing process, material specifications, test data and results, including changes and variations.
● assessment of the API manufacturing site(s) for consistency in production and quality control of raw materials, with specific emphasis on key starting materials or intermediates and the final APIs during and after; purification through compliance with WHO GMP; random sampling and testing of APIs.
● control of storage and distribution.
● handling of complaints and recalls.
● monitoring of complaints from relevant UN agencies and national medicines regulatory authorities of WHO Member States.
WHO will collaborate with national regulators and other organizations on quality assessment and site inspections and recommends that API manufacturers that want to participate in the prequalification of APIs should call on the relevant national authorities to collaborate with WHO in the quality assessment process.
WHO says interested manufacturers are encouraged to submit expressions of interest for API evaluation by sending the required documentation, arranged according to the information provided on the WHO Prequalification Team: medicines (PQTm) website.
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