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 Product8 Submissi<strong>on</strong> of a new or updated c<strong>on</strong>firmati<strong>on</strong> of active <strong>pharmaceutical</strong> ingredient-prequalificati<strong>on</strong> document..........................................................................................................169 Submissi<strong>on</strong> of a new or updated transmissible sp<strong>on</strong>giform encephalopathy EuropeanPharmacopoeia Certificate of Suitability for an excipient or active <strong>pharmaceutical</strong> ingredient(additi<strong>on</strong> or replacement)............................................................................................................175.3 Quality changes........................................................................................................................ 185.3.1 Drug substance (or active <strong>pharmaceutical</strong> ingredient)................................................................185.3.1.1 Manufacture...................................................................................................................1810 Replacement or additi<strong>on</strong> of a new manufacturing site or manufacturer of an active<strong>pharmaceutical</strong> ingredient involving:................................................................................... 1811a change or additi<strong>on</strong> of a manufacturing block/unit at a currently accepted site of active<strong>pharmaceutical</strong> ingredient manufacture.............................................................................. 2012a change in the manufacturing process of the active <strong>pharmaceutical</strong> ingredient................... 2113 Change in the in-process tests or limits applied during the manufacture of the active<strong>pharmaceutical</strong> ingredient:.................................................................................................. 2314 Change in batch size of the active <strong>pharmaceutical</strong> ingredient involving:............................ 2415 Change <strong>to</strong> the specificati<strong>on</strong>s or analytical procedures applied <strong>to</strong> materials used in themanufacture of the active <strong>pharmaceutical</strong> ingredient (e.g. raw materials, startingmaterials, reacti<strong>on</strong> intermediates, solvents, reagents, catalysts) involving:........................ 255.3.1.2 C<strong>on</strong>trol of the active <strong>pharmaceutical</strong> ingredient by the active <strong>pharmaceutical</strong>ingredient manufacturer ................................................................................................2616 Changes <strong>to</strong> the test parameters, acceptance criteria, or analytical procedures of theactive <strong>pharmaceutical</strong> ingredient manufacturer that do not require a change <strong>to</strong> thefinished <strong>pharmaceutical</strong> <strong>product</strong> manufacturer’s active <strong>pharmaceutical</strong> ingredientspecificati<strong>on</strong>s involving:....................................................................................................... 265.3.1.3 C<strong>on</strong>trol of the active <strong>pharmaceutical</strong> ingredient by the finished <strong>pharmaceutical</strong><strong>product</strong> manufacturer.....................................................................................................2717 Change <strong>to</strong> the test parameters or acceptance criteria of the active <strong>pharmaceutical</strong>ingredient specificati<strong>on</strong>s of the finished <strong>pharmaceutical</strong> <strong>product</strong> manufacturerinvolving:............................................................................................................................. 2718 Change <strong>to</strong> the analytical procedures used <strong>to</strong> c<strong>on</strong>trol the active <strong>pharmaceutical</strong> ingredientby the finished <strong>pharmaceutical</strong> <strong>product</strong> manufacturer involving:........................................ 295.3.1.4 C<strong>on</strong>tainer-closure system..............................................................................................3119a Change in the immediate packaging (primary and functi<strong>on</strong>al sec<strong>on</strong>dary comp<strong>on</strong>ents)for the s<strong>to</strong>rage and shipment of the active <strong>pharmaceutical</strong> ingredient................................ 3120 Change in the specificati<strong>on</strong>s of the immediate packaging for the s<strong>to</strong>rage and shipmen<strong>to</strong>f the active <strong>pharmaceutical</strong> ingredient involving:............................................................... 3121 Change <strong>to</strong> an analytical procedure <strong>on</strong> the immediate packaging of the active<strong>pharmaceutical</strong> ingredient involving:................................................................................... 325.3.1.5 Stability...........................................................................................................................3322 Change in the retest period/shelf-life of the active <strong>pharmaceutical</strong> ingredient involving:.... 3323 Change in the labelled s<strong>to</strong>rage c<strong>on</strong>diti<strong>on</strong>s of the active <strong>pharmaceutical</strong> ingredientinvolving:............................................................................................................................. 345.3.2 Drug <strong>product</strong> (or finished <strong>pharmaceutical</strong> <strong>product</strong>).....................................................................34Doc. 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 iv of 70