guidelines on variations to a registered pharmaceutical product

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Guidelines on Variations to a Registered Pharmaceutical ProductDescription of changeConditions tobe fulfilledDocumentationrequired18e.1 deletion of an analytical procedure 6-7 1,6 AN18e.2 6, 8 1, 5, 6 INReportingtype18e.3 None 1, 6 VmajConditions to be fulfilled1. Any new analytical procedure does not concern a novel, non-standard technique or a standardtechnique used in a novel way.2. The change is not necessitated by unexpected events, resulting in failure to meet specifications,arising during manufacture or because of stability concerns.3. No new impurities have been detected as a result of the use of the new analytical method.4. The method of analysis is based on the same analytical technique or principle (e.g. changes to theanalytical procedure are within allowable adjustments to column length, etc., but do not includevariations beyond the acceptable ranges or a different type of column and method), and no newimpurities are detected.5. Comparative studies are available demonstrating that the proposed analytical procedure is at leastequivalent to the currently accepted analytical procedure.6. The change does not concern sterility testing.7. The deleted analytical procedure is an alternate method and is equivalent to a currently acceptedmethod.8. The new or modified analytical method is identical to that used by the API manufacturer and has beenaccepted as part of an amendment to the associated WHO APIMF.Documentation to be supplied1. Copy of the proposed API specifications dated and signed by authorized personnel and a comparativetable of currently accepted and proposed specifications.2. Copies or summaries of analytical procedures, if new or significantly modified analytical proceduresare used.3. Copies or summaries of validation/verification reports issued by the FPP manufacturer, if new orsignificantly modified analytical procedures are used.4. Comparative analytical results demonstrating that the proposed analytical procedures are at leastequivalent to the accepted analytical procedures.5. A copy of the WHO letter of acceptance for APIMF amendment6. Justification for the deletion of the analytical procedure, with supporting data.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 30 of 70
Guidelines on Variations to a Registered Pharmaceutical Product5.3.1.4 Container-closure systemDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype19a Change in the immediate packaging (primary 3, 4 1-2,4 AN19band functional secondary components)1-2, 4 2-3 INfor the storage and shipment of the active19c pharmaceutical ingredient4 1-3 VminConditions to be fulfilled1. Results demonstrate that the proposed primary packaging type is at least equivalent to the currentlyaccepted primary packaging type with respect to its relevant properties (e.g. including results oftransportation or interaction studies, moisture permeability etc.).2. The change does not concern a sterile API.3. The change has previously been accepted through the WHO PQP APIMF procedure.4. The change is not the result of stability issues.Documentation required1. Evidence of process validation and/or evaluation studies for sterilization if different from the currentprocess.2. Information on the proposed primary packaging (e.g. description, specifications etc.) and data infulfillment of condition 1.3. Results of a minimum of three (3) months of accelerated (and intermediate, as appropriate) and three(3) months of long-term testing of the API in the proposed primary packaging type.4. A copy of the WHO letter of acceptance for APIMF amendmentDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype20 Change in the specifications of the immediate packaging for the storage and shipment of theactive pharmaceutical ingredient involving:20a tightening of specification limits 1-2 1 AN20b addition of a test parameter 2-3 1-3 AN20c deletion of a non-critical parameter 2 1,4 AN20d any change (WHO PQP APIMF procedure) 4 No variation is required, suchchanges are handled asamendments to the associatedAPIMFDoc. 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 31 of 70
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