guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
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Guidelines <strong>on</strong> Variati<strong>on</strong>s <strong>to</strong> a Registered Pharmaceutical ProductDocumentati<strong>on</strong> <strong>to</strong> be supplied1. A copy of the WHO letter of acceptance for APIMF amendment2. If the quality characteristics of the API are changed in such a way that it may impact the stability of theFPP, a commitment <strong>to</strong> put under stability <strong>on</strong>e <strong>product</strong>i<strong>on</strong> scale batch of the FPP and <strong>to</strong> c<strong>on</strong>tinue thestudy throughout the currently accepted shelf-life and <strong>to</strong> immediately report any out of specificati<strong>on</strong>results <strong>to</strong> NDA.3. A side-by-side comparis<strong>on</strong> of the current process and the new process.4. A flow diagram of the proposed synthetic process(es) and a brief narrative descripti<strong>on</strong> of the proposedmanufacturing process(es).5. Informati<strong>on</strong> <strong>on</strong> the quality and c<strong>on</strong>trols of the materials (e.g. raw materials, starting materials, solvents,reagents, catalysts) used in the manufacture of the proposed API, where applicable.6. Either a TSE CEP for any new source of material or, where applicable, documented evidence thatthe specific source of the material that carries a risk of TSE has previously been assessed by thecompetent authority and shown <strong>to</strong> comply with the current WHO guideline <strong>on</strong> Transmissible Sp<strong>on</strong>giformEncephalopathies in relati<strong>on</strong> <strong>to</strong> Biological and Pharmaceutical Products or EMA’s Note for Guidance<strong>on</strong> Minimizing the Risk of Transmitting Animal Sp<strong>on</strong>giform Encephalopathy Agents via Human andVeterinary Medicinal Products or an equivalent guideline of the ICH regi<strong>on</strong> and associated countries.7. Informati<strong>on</strong> <strong>on</strong> c<strong>on</strong>trols of critical steps and intermediates, where applicable.8. 8. Evidence of process validati<strong>on</strong> and/or evaluati<strong>on</strong> studies for sterilizati<strong>on</strong>, if applicable.9. Evidence for elucidati<strong>on</strong> of structure, where applicable.10. Informati<strong>on</strong> <strong>on</strong> impurities.11. A copy of currently accepted specificati<strong>on</strong>s of API (and starting material and intermediate, if applicable).12. Descripti<strong>on</strong> of the batches, certificates of analysis or batch analysis report, and summary of results, ina comparative tabular format, for at least two batches (minimum pilot scale) manufactured according<strong>to</strong> the current and proposed processes.13. Results of two batches of at least pilot scale with a minimum of three (3) m<strong>on</strong>ths of accelerated (andintermediate as appropriate) and three (3) m<strong>on</strong>ths of l<strong>on</strong>g-term testing of the proposed API.14. For low solubility APIs where the polymorphic form has changed or whenever particle size is critical(including low solubility APIs) where there is dissimilar particle size distributi<strong>on</strong> compared <strong>to</strong> the lotused in the biobatch, evidence that the differences do not impact the quality and bioavailability of theFPPDoc. No.: DAR/GDL/005 Revisi<strong>on</strong> Date: 8 th July 2013 Review Due Date: 16 th July 2016Revisi<strong>on</strong> No.: 1 Effective Date : 16 th July 2013 Page 22 of 70