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 Product6. No change in the FPP release and end-of-shelf-life specificati<strong>on</strong>s.7. No difference in impurity profile of the proposed API <strong>to</strong> be supplied, including organic, inorganic andgeno<strong>to</strong>xic impurities and residual solvents. The proposed API manufacturer’s specificati<strong>on</strong>s do notrequire the revisi<strong>on</strong> of the FPP manufacturer’s API specificati<strong>on</strong>s.8. For low solubility APIs the API polymorph is the same, and whenever particle size is critical (includinglow solubility APIs) there is no significant difference in particle size distributi<strong>on</strong>, compared <strong>to</strong> the APIlot used in the preparati<strong>on</strong> of the biobatch.9. Specificati<strong>on</strong>s (including in-process c<strong>on</strong>trols, methods of analysis of all materials), method ofmanufacture (including batch size) and detailed route of synthesis are verified as identical <strong>to</strong> thosealready accepted (such situati<strong>on</strong>s are generally limited <strong>to</strong> additi<strong>on</strong>al sites by the same manufactureror new c<strong>on</strong>tract manufacturing site with evidence of an acceptable and similar quality system <strong>to</strong> themain manufacturer).10. Where materials of human or animal origin are used in the process, the manufacturer does not useany new supplier for which assessment is required of viral safety or of compliance with the currentWHO Guidelines <strong>on</strong> Transmissible Sp<strong>on</strong>giform Encephalopathies in relati<strong>on</strong> <strong>to</strong> Biological andPharmaceutical Products or EMA’s Note for Guidance <strong>on</strong> Minimizing the Risk of Transmitting AnimalSp<strong>on</strong>giform Encephalopathy Agents via Human and Veterinary Medicinal Products or an equivalentguideline of the ICH regi<strong>on</strong> and associated countries.Documentati<strong>on</strong> required1. Name, address, and resp<strong>on</strong>sibility of the proposed site or facility involved in manufacture or testing(including block(s) and unit(s). A valid testing authorizati<strong>on</strong> or a certificate of GMP compliance, ifapplicable.2. A side-by-side comparis<strong>on</strong> of the manufacturing flowcharts for <strong>product</strong>i<strong>on</strong> of the API, intermediate, orAPI starting material (as applicable) at the parent and proposed sites.3. Copies or summaries of validati<strong>on</strong> reports or method transfer reports, which dem<strong>on</strong>strate equivalencyof analytical procedures <strong>to</strong> be used at the proposed testing site.4. Descripti<strong>on</strong> of the batches, copies of certificates of analysis and batch analysis data (in a comparativetabular format) for at least two (minimum pilot scale) batches of the API from the currently acceptedand proposed manufacturers/sites.5. Relevant secti<strong>on</strong>s of (S) documentati<strong>on</strong> in fulfillment of requirements for full informati<strong>on</strong> provided inthe dossier6. The open part of the new APIMF (with a Letter of Access provided in Module 1)7. 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.8. A copy of the FPP manufacturer’s API specificati<strong>on</strong>s.Doc. 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 19 of 70