guidelines on variations to a registered pharmaceutical product

Guidelines on Variations to a Registered Pharmaceutical Product4. Any new analytical procedure does not concern a novel, non-standard technique or a standardtechnique used in a novel way.5. The deleted analytical procedure is an alternate method and is equivalent to a currently acceptedmethod.6. The change has previously been accepted through the WHO PQP APIMF procedure.Documentation required1. Comparative validation results demonstrating that the currently accepted and proposed proceduresare at least equivalent.2. Justification for deletion of the analytical procedure.5.3.1.5 StabilityDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype22 Change in the retest period/shelf-life of the active pharmaceutical ingredient involving:22a any change (WHO PQP APIMF procedure -related)4 4 IN22b reduction 3 1-2 IN22c extension 1-2 1-3 VminConditions to be fulfilled1. No change to the primary packaging in direct contact with the API or to the recommended conditionof storage.2. Stability data was generated in accordance with the currently accepted stability protocol.3. The change is not necessitated by unexpected events arising during manufacture or because ofstability concerns.4. The revised retest period has previously been accepted through the WHO PQP APIMF procedure.Documentation required1. Proposed retest period/shelf-life, summary of stability testing according to currently accepted protocoland test results.2. Updated post-acceptance stability protocol and stability commitment and justification of change, whenapplicable.3. Stability data.4. A copy of the WHO letter of acceptance for APIMF amendment.Doc. No.: DAR/GDL/005 Revision Date: 8 th July 2013 Review Due Date: 16 th July 2016Revision No.: 1 Effective Date : 16 th July 2013 Page 33 of 70