WHO will furthermore arrange for the products and manufacturing sites included in the list to be re-evaluated at regular intervals. If, as a result of this re-evaluation, it is found that a product and/or specified manufacturing site no longer complies with the WHO-recommended standards, such products and manufacturing sites will be removed from the list. Failure of a manufacturer or applicant to participate in the re-evaluation procedure will also lead to removal from the list.Re-evaluation, including re-inspections of manufacturing sites and contract research organizations (CROs), will be done at regular intervals, based on risk assessment, but at least once every 5 years.Re-evaluation, including re-inspections, shall also be performed:• if any fraud or omissions by the applicant, manufacturer(s) of a finished pharmaceutical product (FPP) or active pharmaceutical ingredient (API), or CROs in the initial assessment procedure or during the follow-up activities, becomes evident; and• if WHO or any United Nations agency considers that a batch or batches of supplied prequalified pharmaceutical products are not in compliance with the specifications which were found to be applicable upon prequalification.
• A covering letter, which should contain a clear statement by the responsible person submitting the quality review, indicating that the information submitted is true and correct.• Summary of key product information (as per Appendix 1).• Variations to the product(as per Appendix 2).• A pharmaceutical quality information form (PQIF), completed in WinWord format. It should reflect the requirements of current prequalification guidelines and should also take into account technical and scientific progress. The API and FPP specifications should be provided in tabulated format, comparing the specifications at prequalification and at the time of the requalification submission.• Copies of the current API and FPP specifications, duly signed and dated, including the test methods. The specifications should indicate the reference number, version number, effective date and change history if any.
Item |
Prequalified dossier |
Current data |
Product number (e.g. HA001) |
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INN, strength and pharmaceutical form |
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Applicant (name, physical address and contact numbers) |
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Manufacturing site(s) of FPP, with physical address (including unit and block numbers) and contact numbers (list separately if different steps are performed by different sites, e.g. packaging, quality control) |
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Batch size(s) of FPP |
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Product description (visual appearance) |
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Primary and secondary packaging material(s) and pack size(s) |
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Storage conditions of FPP |
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Shelf-life of FPP |
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FPP specification(s) reference number and/or version |
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Manufacturer(s) of API(s), with physical address (including unit and
block numbers) and contact numbers (list each API separately) |
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Number/version of each APIMF associated with the FPP |
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Storage conditions of API |
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Retest period of API(s) |
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API specification(s) reference number and/or version (for each API) |
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All commitments and their outcomes |
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INN, international nonproprietary name; FPP, finished pharmaceutical product; API, active pharmaceutical ingredient; APIMF, active pharmaceutical ingredient master file.
a If there has been no update of the dossier then indicate “N/A” (not applicable).
b According to the latest editions of The International Pharmacopoeia (Ph.Int.), the European Pharmacopoeia (Ph.Eur), the British Pharmacopoeia (BP) and/or the United States Pharmacopeia (USP). Where in-house specifi cations have been approved and there is now a monograph in any of the internationally-recognized pharmacopoeias (Ph.Int., Ph.Eur, BP, or USP), the specifications should be updated to comply with the new monograph or demonstrated to be at least equivalent. In the case that no compendial monograph exists, the applicant should ensure that the approved inhouse specifi cations are updated, through the variation process, to reflect the requirements of current prequalification guidelines and to take into account technical and scientific progress (e.g. current ICH guidelines, general chapters of the Ph.Int.). Each new version of the documents should allow traceability to the prequalified dossier and approved variations.
Reference no. |
Date of submission |
Date of approval/ rejection and reference number of the letter |
Date of implementation |
Major changes |
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Description of the change, e.g. change in the primary packaging site of
a sterile product |
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Minor changes |
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Description of the change according to the PQ variation guide |
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