guidelines on variations to a registered pharmaceutical product

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Guidelines on Variations to a Registered Pharmaceutical ProductDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype23 Change in the labelled storage conditions of the active pharmaceutical ingredient involving:23aany change in storage conditions (WHOPQP APIMF procedure-related)1 1 IN23b any change in storage conditions 2 2 VminConditions to be fulfilled1. The revised storage conditions have previously been accepted through the APIMF procedure.2. The change is not necessitated by unexpected events, resulting in failure to meet specifications,arising during manufacture or because of stability concerns.Documentation required1. A copy of the WHO letter of acceptance for APIMF amendment.2. If applicable, stability and/or compatibility test results to support the change to the storage conditions.5.3.2 Drug product (or finished pharmaceutical product)5.3.2.1 Description and composition of the finished pharmaceutical productDescription of changeConditions to befulfilledDocumentationrequiredReporting type24aChange in the1-6 2,4,7,9-10 IN24bcomposition of asolution dosage formNone 1-11 VmajConditions to be fulfilled1. The affected excipient(s) does/do not function to affect the solubility and/or the absorption of the API.2. The affected excipient(s) does/do not function as a preservative or preservative enhancer.3. No change in the specifications of the affected excipient(s) or the FPP.4. No change in the physical characteristics of the FPP (e.g. viscosity, osmolality, pH).5. The change does not concern a sterile FPP.6. The excipients are qualitatively the same. The change in the amount (or concentration) of eachexcipient is within ±10% of the amount (or concentration) of each excipient in the originally prequalifiedproduct.Documentation required1. Supporting clinical or comparative bioavailability data or justification for not submitting a newbioequivalence study according to the current Authority Guidelines on Bioequivalence.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 34 of 70
Guidelines on Variations to a Registered Pharmaceutical Product2. Description and composition of the FPP.3. Discussion on the components of the proposed product (e.g. choice of excipients, compatibility of APIand excipients, suitability studies on the packaging system for the changed product).4. Batch formula, description of manufacturing process and process controls, controls of critical stepsand intermediates, process validation protocol and/or evaluation.5. Control of excipients, if new excipients are proposed.6. If applicable, either a CEP for any new component of animal origin susceptible to TSE risk or whereapplicable, documented evidence that the specific source of the TSE risk material has been previouslyassessed by an NMRA in the ICH region or associated countries and shown to comply with the scopeof the current guideline in the countries of the ICH region or associated countries. The followinginformation should be included for each such material: name of manufacturer, species and tissuesfrom which the material is derived, country of origin of the source animals and its use.7. Copies of FPP release and shelf-life specifications and certificates of analysis for a minimum of twopilot or production scale batches. If applicable, data to demonstrate that the new excipient does notinterfere with the analytical procedures for the FPP.8. 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.9. Updated post-acceptance stability protocol and stability commitment to place the first production scalebatch of each strength of the proposed product into the long-term stability programme (bracketing andmatrixing for multiple strengths and packaging components could be applied, if scientifically justified).10. Copies of relevant pages of blank master production documents with changes highlighted, as well asrelevant pages of the executed production document for one batch and confirmation that there are nochanges to the production documents other than those highlighted.11. Samples of the productDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype25 Change in the colouring system or the flavouring system currently used in the finishedpharmaceutical product involving25a25breduction or increase of one or morecomponents of the colouring or the flavouringsystemdeletion, addition or replacement of one ormore components of the colouring or theflavouring system1-3,6 1,4,6-7 AN1-6 1-7 INDoc. 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 35 of 70
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guidelines on variations to a registered pharmaceutical product

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