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 Product4. Justificati<strong>on</strong> for the proposed FPP specificati<strong>on</strong>s.5. Dem<strong>on</strong>strati<strong>on</strong> of the suitability of the m<strong>on</strong>ograph <strong>to</strong> c<strong>on</strong>trol the FPP.Descripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype41 Change in the specificati<strong>on</strong>s of the finished <strong>pharmaceutical</strong> <strong>product</strong> involving test parametersand acceptance criteria:41a deleti<strong>on</strong> of a test parameter 5 1,6 AN41b additi<strong>on</strong> of a test parameter 2-4, 7 1-6 AN41c tightening of an acceptance criteri<strong>on</strong> 1-2 1,6 AN41d relaxati<strong>on</strong> of an acceptance criteri<strong>on</strong> 2,4,6-7 1,5-6 IN41e replacement of a test parameter 2-4,6-7 1-6 INC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1. The change is within the range of currently accepted limits.2. 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 additi<strong>on</strong>al impurity found over the ICH identificati<strong>on</strong> threshold.5. The deleted test has been dem<strong>on</strong>strated <strong>to</strong> be redundant with respect <strong>to</strong> the remaining tests.6. The change <strong>to</strong> the specificati<strong>on</strong>s does not affect the stability and the performance of the <strong>product</strong>.7. The change does not c<strong>on</strong>cern sterility testing.Documentati<strong>on</strong> required1. Copy of the proposed FPP specificati<strong>on</strong>s dated and signed by authorized pers<strong>on</strong>nel and a comparativetable of currently accepted and proposed specificati<strong>on</strong>s.2. Copies or summaries of analytical procedures, if new analytical procedures are used.3. Copies or summaries of validati<strong>on</strong> reports, if new analytical procedures are used.4. Where an in-house analytical procedure is used and a pharmacopoeial standard is claimed, results ofan equivalency study between the in-house and pharmacopoeial methods.5. Descripti<strong>on</strong> of the batches, certificates of analysis for at least <strong>on</strong>e batch (minimum pilot scale) andcomparative summary of results, in tabular format, for <strong>on</strong>e batch using currently accepted and proposedprocedures, if new analytical procedures are implemented.6. Justificati<strong>on</strong> for the proposed FPP specificati<strong>on</strong>s.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 49 of 70