guidelines on variations to a registered pharmaceutical product

Guidelines on Variations to a Registered Pharmaceutical ProductConditions to be fulfilled1. The change is not necessitated by unexpected events arising during manufacture or because ofstability concerns.Documentation required1. Proposed in-use period, test results and justification of change.2. Copy of currently accepted end of shelf-life FPP specifications and where applicable, specificationsafter dilution/reconstitution.3. Revised label information4. Samples of the productDescription of changeConditions tobe fulfilledDocumentationrequiredReportingtype53 Change in the labelled storage conditionsof the finished pharmaceutical product (aspackaged for sale), the product during the inuseperiod or the product after reconstitution ordilutionConditions to be fulfilled1 1-4 Vmin1. The change is not necessitated by unexpected events, resulting in failure to meet specifications,arising during manufacture or because of stability concerns.Documentation required1. If applicable, stability and/or compatibility test results to support the change to the storage conditions.2. Updated post-acceptance stability protocol and stability commitment and justification of change.3. Revised label information.4. Samples of the productDoc. 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 57 of 70