guidelines on variations to a registered pharmaceutical product

Guidelines on Variations to a Registered Pharmaceutical ProductDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype37 Change in source of an excipient from atransmissible spongiform encephalopathy riskto a material of vegetable or synthetic origin.1 1 ANConditions to be fulfilled1. No change in the excipient and FPP release and shelf-life specifications.Documentation required1. Declaration from the manufacturer of the excipient that it is entirely of vegetable or synthetic origin.5.3.2.3 Control of excipientsDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype38 Change in the specifications or analytical procedures of an excipient involving:38a38bdeletion of a non-significant in-houseparameteraddition of a new test parameter or analyticalprocedure2 1-3 AN2-3 1-2 AN38c tightening of specification limits 1-2,4 1-2 AN38dchange or replacement of an analyticalprocedureConditions to be fulfilled1. The change is within the range of currently accepted limits.2-3 1-2 Vmin2. 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 change in the analytical procedure.Documentation required1. Justification for the change.2. Comparative table of currently accepted and proposed specifications, justification of the proposedspecifications and details of procedure and summary of validation of any new analytical procedure (ifapplicable).3. Justification to demonstrate that the parameter is not critical.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 47 of 70