guidelines on variations to a registered pharmaceutical product

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Guidelines on Variations to a Registered Pharmaceutical ProductConditions to be fulfilled1. No change in the functional characteristics of the pharmaceutical form e.g. disintegration time,dissolution profile etc.2. Any minor adjustment to the formulation to maintain the total weight is made by an excipient whichcurrently makes up a major part of the FPP formulation.3. Specifications for the FPP are updated only with respect to appearance/odour /taste or if relevant,deletion or addition of a test for identification.4. Any new component must comply with the relevant section of NDA “Guidelines on Submission ofDocumentation for Marketing Authorization of a Registered Pharmaceutical Product for Human Use“,and ‘Guidelines for registration of Veterinary drugs’5. Any new component does not include the use of materials of human or animal origin for whichassessment is required of viral safety data, or is in compliance with the current WHO Guideline onTransmissible Spongiform Encephalopathies in relation to Biological and Pharmaceutical Products orEMA’s Note for Guidance on Minimizing the Risk of Transmitting Animal Spongiform EncephalopathyAgents via Human and Veterinary Medicinal Products or an equivalent guide of the ICH region andassociated countries.6. For paediatric products, the change does not require submission of results of palatability studies.Documentation required1. Samples of the product2. Discussion on the components of the FPP (e.g. compatibility of API and qualitative composition of thecolouring or flavouring system if purchased as a mixture, with specifications, if relevant).3. Either a CEP for any new component of animal origin susceptible to TSE risk or where applicable,documented evidence that the specific source of the TSE risk material has been previously assessedby an NMRA in the ICH region or associated countries and shown to comply with the scope of thecurrent guideline in the countries of the ICH region or associated countries. The following informationshould be included for each such material: name of manufacturer, species and tissues from which thematerial is derived, country of origin of the source animals and its use.4. Copies of revised FPP release and shelf-life specifications and certificates of analysis for a minimumof two pilot or production scale batches.5. If applicable, data to demonstrate that the new excipient does not interfere with the analyticalprocedures for the FPP.6. Results of stability testing generated on at least two pilot or production scale batches with a minimumof three (3) months of accelerated (and intermediate, as appropriate) and three (3) months of longtermtesting.7. Copies of relevant sections of blank master production documents with changes highlighted as well asrelevant pages of the executed production documents for one batch and confirmation that there are nochanges to the production documents other than those highlighted.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 36 of 70
Guidelines on Variations to a Registered Pharmaceutical ProductDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype26 Change in weight of tablet coatings or capsule shells involving26a immediate-release oral FPPs 1-3 2-5 AN26bgastro-resistant, modified or prolonged releaseFPPsConditions to be fulfilledNone 1-5 Vmaj1. Multipoint in vitro dissolution profiles of the proposed version of the product (determined in the releasemedium on at least two batches of pilot or production scale), are similar to the dissolution profiles ofthe biobatch.2. Coating is not a critical factor for the release mechanism.3. Specifications for the FPP are updated only with respect to weight and dimensions, if applicable.Documentation required1. Justification for not submitting a new bioequivalence study according to the current Authority Guidelineson Bioequivalence.2. Comparative multipoint in vitro dissolution profiles in the release medium (or media), on at least twobatches of pilot or production scale of the proposed product versus the biobatch.3. Copies of revised FPP release and shelf-life specifications and certificates of analysis for a minimumof one pilot or production scale batch.4. Results of stability testing generated on at least one pilot or production scale batch with a minimum ofthree (3) months of accelerated (and intermediate, as appropriate) and three (3) months of long-termtesting.5. Copies of relevant sections of blank master production documents with changes highlighted as well asrelevant pages of the executed production documents for one batch and confirmation that there are nochanges to the production documents other than those highlighted.Description of changeConditions tobe fulfilledDocumentationrequiredReportingtype27 Change in the composition of an immediate-release solid oral dosage form including27a.1 replacement of a single excipient with a 1-5 1-10 Vmin27a.2comparable excipient at a similar levelNone 1-10 Vmaj27b.1 quantitative changes in excipients 1-4 1-4, 7-10 Vmin27b.2 None 1-4, 7-10 VmajDoc. 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 37 of 70
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