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 ProductDescripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype37 Change in source of an excipient from atransmissible sp<strong>on</strong>giform encephalopathy risk<strong>to</strong> a material of vegetable or synthetic origin.1 1 ANC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1. No change in the excipient and FPP release and shelf-life specificati<strong>on</strong>s.Documentati<strong>on</strong> required1. Declarati<strong>on</strong> from the manufacturer of the excipient that it is entirely of vegetable or synthetic origin.5.3.2.3 C<strong>on</strong>trol of excipientsDescripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype38 Change in the specificati<strong>on</strong>s or analytical procedures of an excipient involving:38a38bdeleti<strong>on</strong> of a n<strong>on</strong>-significant in-houseparameteradditi<strong>on</strong> of a new test parameter or analyticalprocedure2 1-3 AN2-3 1-2 AN38c tightening of specificati<strong>on</strong> limits 1-2,4 1-2 AN38dchange or replacement of an analyticalprocedureC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> 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 <strong>to</strong> meet specificati<strong>on</strong>s,arising during manufacture or because of stability c<strong>on</strong>cerns.3. Any new analytical procedure does not c<strong>on</strong>cern a novel, n<strong>on</strong>-standard technique or a standardtechnique used in a novel way.4. No change in the analytical procedure.Documentati<strong>on</strong> required1. Justificati<strong>on</strong> for the change.2. Comparative table of currently accepted and proposed specificati<strong>on</strong>s, justificati<strong>on</strong> of the proposedspecificati<strong>on</strong>s and details of procedure and summary of validati<strong>on</strong> of any new analytical procedure (ifapplicable).3. Justificati<strong>on</strong> <strong>to</strong> dem<strong>on</strong>strate that the parameter is not critical.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 47 of 70