guidelines on variations to a registered pharmaceutical product

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Guidelines on Variations to a Registered Pharmaceutical ProductDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype39 Change in specifications of an excipientto comply with an officially recognizedpharmacopoeia1 1 ANConditions to be fulfilled1. No change to the specifications other than those required to comply with the pharmacopoeia (e.g. nochange in particle size distribution).Documentation required1. Comparative table of currently accepted and proposed specifications for the excipient.5.3.2.4 Control of a finished pharmaceutical productDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype40a40bChange in the standard claimed for thefinished pharmaceutical product froman in-house to an officially recognizedpharmacopoeial standard.Update to the specifications to comply withan officially recognized pharmacopoeialmonograph as a result of an update to thismonograph to which the FPP is controlledConditions to be fulfilled1-3 1-5 ANNone 1, 3, 5 AN1. The change is made exclusively to comply with the officially recognized pharmacopoeia.2. No change to the specifications that result in a potential impact on the performance of the FPP (e.g.dissolution test).3. No deletion of or relaxation to any of the tests, analytical procedures or acceptance criteria of thespecifications.Documentation required1. Copy of the proposed FPP specifications dated and signed by authorized personnel and a comparativetable of currently accepted and proposed specifications.2. Where an in-house analytical procedure is used and a pharmacopoeial standard is claimed, results ofan equivalency study between the in-house and pharmacopoeial methods.3. Description of the batches, certificates of analysis for at least one batch (minimum pilot scale)and comparative summary of results, in tabular format, for one batch using current and proposedprocedures, if new analytical procedures are implemented.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 48 of 70
Guidelines on Variations to a Registered Pharmaceutical Product4. Justification for the proposed FPP specifications.5. Demonstration of the suitability of the monograph to control the FPP.Description of changeConditions tobe fulfilledDocumentationrequiredReportingtype41 Change in the specifications of the finished pharmaceutical product involving test parametersand acceptance criteria:41a deletion of a test parameter 5 1,6 AN41b addition of a test parameter 2-4, 7 1-6 AN41c tightening of an acceptance criterion 1-2 1,6 AN41d relaxation of an acceptance criterion 2,4,6-7 1,5-6 IN41e replacement of a test parameter 2-4,6-7 1-6 INConditions to be fulfilled1. The change is within the range of currently accepted limits.2. The change is not necessitated by unexpected events, resulting in failure to meet specifications,arising during manufacture or because of stability concerns.3. Any new analytical procedure does not concern a novel, non-standard technique or a standardtechnique used in a novel way.4. No additional impurity found over the ICH identification threshold.5. The deleted test has been demonstrated to be redundant with respect to the remaining tests.6. The change to the specifications does not affect the stability and the performance of the product.7. The change does not concern sterility testing.Documentation required1. Copy of the proposed FPP 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 analytical procedures are used.3. Copies or summaries of validation reports, if new analytical procedures are used.4. Where an in-house analytical procedure is used and a pharmacopoeial standard is claimed, results ofan equivalency study between the in-house and pharmacopoeial methods.5. Description of the batches, certificates of analysis for at least one batch (minimum pilot scale) andcomparative summary of results, in tabular format, for one batch using currently accepted and proposedprocedures, if new analytical procedures are implemented.6. Justification for the proposed FPP specifications.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 49 of 70
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