guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
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Guidelines <strong>on</strong> Variati<strong>on</strong>s <strong>to</strong> a Registered Pharmaceutical ProductC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1. The change is not necessitated by unexpected events arising during manufacture or because ofstability c<strong>on</strong>cerns.Documentati<strong>on</strong> required1. Proposed in-use period, test results and justificati<strong>on</strong> of change.2. Copy of currently accepted end of shelf-life FPP specificati<strong>on</strong>s and where applicable, specificati<strong>on</strong>safter diluti<strong>on</strong>/rec<strong>on</strong>stituti<strong>on</strong>.3. Revised label informati<strong>on</strong>4. Samples of the <strong>product</strong>Descripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype53 Change in the labelled s<strong>to</strong>rage c<strong>on</strong>diti<strong>on</strong>sof the finished <strong>pharmaceutical</strong> <strong>product</strong> (aspackaged for sale), the <strong>product</strong> during the inuseperiod or the <strong>product</strong> after rec<strong>on</strong>stituti<strong>on</strong> ordiluti<strong>on</strong>C<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1 1-4 Vmin1. The change is not necessitated by unexpected events, resulting in failure <strong>to</strong> meet specificati<strong>on</strong>s,arising during manufacture or because of stability c<strong>on</strong>cerns.Documentati<strong>on</strong> required1. If applicable, stability and/or compatibility test results <strong>to</strong> support the change <strong>to</strong> the s<strong>to</strong>rage c<strong>on</strong>diti<strong>on</strong>s.2. Updated post-acceptance stability pro<strong>to</strong>col and stability commitment and justificati<strong>on</strong> of change.3. Revised label informati<strong>on</strong>.4. Samples of the <strong>product</strong>Doc. No.: DAR/GDL/005 Revisi<strong>on</strong> Date: 8 th July 2013 Review Due Date: 16 th July 2016Revisi<strong>on</strong> No.: 1 Effective Date : 16 th July 2013 Page 57 of 70