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 Product4. Any new analytical procedure does not c<strong>on</strong>cern a novel, n<strong>on</strong>-standard technique or a standardtechnique used in a novel way.5. The deleted analytical procedure is an alternate method and is equivalent <strong>to</strong> a currently acceptedmethod.6. The change has previously been accepted through the WHO PQP APIMF procedure.Documentati<strong>on</strong> required1. Comparative validati<strong>on</strong> results dem<strong>on</strong>strating that the currently accepted and proposed proceduresare at least equivalent.2. Justificati<strong>on</strong> for deleti<strong>on</strong> of the analytical procedure.5.3.1.5 StabilityDescripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype22 Change in the retest period/shelf-life of the active <strong>pharmaceutical</strong> ingredient involving:22a any change (WHO PQP APIMF procedure -related)4 4 IN22b reducti<strong>on</strong> 3 1-2 IN22c extensi<strong>on</strong> 1-2 1-3 VminC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1. No change <strong>to</strong> the primary packaging in direct c<strong>on</strong>tact with the API or <strong>to</strong> the recommended c<strong>on</strong>diti<strong>on</strong>of s<strong>to</strong>rage.2. Stability data was generated in accordance with the currently accepted stability pro<strong>to</strong>col.3. The change is not necessitated by unexpected events arising during manufacture or because ofstability c<strong>on</strong>cerns.4. The revised retest period has previously been accepted through the WHO PQP APIMF procedure.Documentati<strong>on</strong> required1. Proposed retest period/shelf-life, summary of stability testing according <strong>to</strong> currently accepted pro<strong>to</strong>coland test results.2. Updated post-acceptance stability pro<strong>to</strong>col and stability commitment and justificati<strong>on</strong> of change, whenapplicable.3. Stability data.4. A copy of the WHO letter of acceptance for APIMF amendment.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 33 of 70