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 ProductC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1. No change in the FPP release and shelf-life specificati<strong>on</strong>s.2. Unchanged (excluding tightening) additi<strong>on</strong>al (<strong>to</strong> Ph.Eur.) specificati<strong>on</strong>s for any impurities includingorganic, inorganic and geno<strong>to</strong>xic impurities and residual solvents, with the excepti<strong>on</strong> of residualsolvents when the limits stipulated comply with ICH requirements.3. The manufacturing process of the API, starting material or intermediate does not include the use ofmaterials of human or animal origin for which an assessment of viral safety data is required.4. For low solubility APIs the polymorph is the same, and whenever particle size is critical (including lowsolubility APIs) there is no significant difference in particle size distributi<strong>on</strong>, compared <strong>to</strong> the API lotused in the preparati<strong>on</strong> of the biobatch.5. No revisi<strong>on</strong> of the FPP manufacturer’s API specificati<strong>on</strong>s is required.Documentati<strong>on</strong> <strong>to</strong> be supplied1. Copy of the current (updated) CEP, including any annexes and a declarati<strong>on</strong> of access for the CEP <strong>to</strong>be duly filled out by the CEP holder <strong>on</strong> behalf of the FPP manufacturer or applicant <strong>to</strong> NDA who refers<strong>to</strong> the CEP.2. A written commitment that the applicant will inform NDA in the event that the CEP is withdrawn andan acknowledgement that withdrawal of the CEP will require additi<strong>on</strong>al c<strong>on</strong>siderati<strong>on</strong> of the API datarequirements <strong>to</strong> support the <strong>product</strong> dossier.3. Replacement of the relevant pages of the dossier with the revised informati<strong>on</strong> for the CEP submissi<strong>on</strong>opti<strong>on</strong> stipulated under secti<strong>on</strong> 3.2.S of NDA Guidelines <strong>on</strong> Submissi<strong>on</strong> of Documentati<strong>on</strong> for MarketingAuthorizati<strong>on</strong> of a Registered Pharmaceutical Product for Human Use“.4. For sterile APIs, data <strong>on</strong> the sterilizati<strong>on</strong> process of the API, including validati<strong>on</strong> data.5. In the case of the submissi<strong>on</strong> of a CEP for an API, if the quality characteristics of the API are changedin such a way that it may impact the stability of the FPP, a commitment <strong>to</strong> put under stability <strong>on</strong>e batchof the FPP of at least pilot scale, and <strong>to</strong> c<strong>on</strong>tinue the study throughout the currently accepted shelf-lifeand <strong>to</strong> immediately report any out of specificati<strong>on</strong> results <strong>to</strong> NDA.6. Copy of FPP manufacturer’s revised API specificati<strong>on</strong>s.Descripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> befulfilledDocumentati<strong>on</strong>requiredReportingtype8 Submissi<strong>on</strong> of a new or updated c<strong>on</strong>firmati<strong>on</strong> of active <strong>pharmaceutical</strong> ingredient -prequalificati<strong>on</strong>document8a.1 from a currently WHO prequalified API 1-3 1-3, 5 AN8a.2manufacturer1-2 1-5 Vmin8b.1 from a new manufacturer 1-3 1-3, 5 IN8b.2 1-2 1-5 VminDoc. 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 16 of 70