guidelines on variations to a registered pharmaceutical product

Guidelines on Variations to a Registered Pharmaceutical Product6. Appropriate validation studies have been performed in accordance with the relevant <strong>guidelines</strong> andshow that the updated analytical procedure is at least equivalent to the former analytical procedure.7. No change to the total impurity limits; no new impurities are detected.8. Any new analytical procedure does not concern a novel non-standard technique or a standardtechnique used in a novel way.9. The change does not concern a genotoxic impurity.10. The affected parameter is non-significant or the alternative analytical procedure has been previouslyaccepted.Documentation to be supplied1. Comparative table of currently accepted and proposed specifications.2. Information on the quality and controls of the materials (e.g. raw materials, starting materials, solvents,reagents, catalysts) used in the manufacture of the proposed API, where applicable.3. Information on intermediates, where applicable.4. Justification/risk-assessment showing that the parameter is non-significant.5. Information on impurities, where applicable.5.3.1.2 Control of the active pharmaceutical ingredient by the active pharmaceutical ingredientmanufacturerDescription of changeConditions tobe fulfilledDocumentationrequiredReporting type16 Changes to the test parameters, acceptance criteria, or analytical procedures of the activepharmaceutical ingredient manufacturer that do not require a change to the finishedpharmaceutical product manufacturer’s active pharmaceutical ingredient specifications involving:16a16ba. API supported through the WHO PQPAPIMF procedure.b. API not supported through the WHO PQPAPIMF procedure.Conditions to be fulfilled1-2 No variation is required, suchchanges are handled asamendments to the associatedAPIMF2 1-4 IN1. The revised test parameters, acceptance criteria, or analytical procedures have been submitted asamendments to the associated APIMF and accepted.2. The API manufacturer has provided the relevant documentation to the FPP manufacturer. The FPPmanufacturer has considered the API manufacturer’s revisions and determined that no consequentialrevisions to the FPP manufacturer’s API test parameters, acceptance criteria, or analytical proceduresare required to ensure that adequate control of the API is maintained.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 26 of 70