guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
guidelines on variations to a registered pharmaceutical product
- No tags were found...
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Guidelines <strong>on</strong> Variati<strong>on</strong>s <strong>to</strong> a Registered Pharmaceutical Product3. Dem<strong>on</strong>strati<strong>on</strong> of the uniformity of the dosage units of the tablet porti<strong>on</strong>s, where the scoring is intended<strong>to</strong> divide the FPP in<strong>to</strong> equal doses.4. Dem<strong>on</strong>strati<strong>on</strong> of the similarity of the release rate of the tablet porti<strong>on</strong>s for gastro-resistant, modifiedor prol<strong>on</strong>ged release <strong>product</strong>s.5. Copies of revised FPP release and shelf-life specificati<strong>on</strong>s.6. Copies of relevant secti<strong>on</strong>s of blank master <strong>product</strong>i<strong>on</strong> documents with changes highlighted as wellas relevant pages of the executed <strong>product</strong>i<strong>on</strong> documentati<strong>on</strong> for <strong>on</strong>e batch and c<strong>on</strong>firmati<strong>on</strong> that thereare no changes <strong>to</strong> the <strong>product</strong>i<strong>on</strong> documents other than those highlighted.Descripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong>be fulfilledDocumentati<strong>on</strong>requiredReportingtype29 Change in dimensi<strong>on</strong>s without change in qualitative or quantitative compositi<strong>on</strong> and mean massof::29a29btablets, capsules, supposi<strong>to</strong>ries andpessaries other than those stated in change#27bgastro-resistant, modified or prol<strong>on</strong>gedrelease FPPs and scored tabletsC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1-2 2-6 IN1-2 1-6 Vmin1. Specificati<strong>on</strong>s for the FPP are updated <strong>on</strong>ly with respect <strong>to</strong> dimensi<strong>on</strong>s of the FPP.2. Multipoint in vitro dissoluti<strong>on</strong> profiles of the current and proposed versi<strong>on</strong>s of the <strong>product</strong> (determinedin the release medium, <strong>on</strong> at least <strong>on</strong>e batch of pilot or <strong>product</strong>i<strong>on</strong> scale), are comparable.Documentati<strong>on</strong> required1. Justificati<strong>on</strong> for not submitting a new bioequivalence study according <strong>to</strong> the current WHO Guidelines<strong>on</strong> Bioequivalence.2. Samples of the Product.3. Discussi<strong>on</strong> <strong>on</strong> the differences in manufacturing process(es) between the currently accepted andproposed <strong>product</strong>s and the potential impact <strong>on</strong> <strong>product</strong> performance.4. Comparative multipoint in vitro dissoluti<strong>on</strong> profiles in the release medium, <strong>on</strong> at least <strong>on</strong>e batch of pilo<strong>to</strong>r <strong>product</strong>i<strong>on</strong> scale of the current and proposed <strong>product</strong>s.5. Copies of revised FPP release and shelf-life specificati<strong>on</strong>s.6. Copies of relevant secti<strong>on</strong>s of blank master <strong>product</strong>i<strong>on</strong> documents with changes highlighted as well asrelevant pages of executed <strong>product</strong>i<strong>on</strong> documentati<strong>on</strong> for <strong>on</strong>e batch and c<strong>on</strong>firmati<strong>on</strong> that there are nochanges <strong>to</strong> the <strong>product</strong>i<strong>on</strong> documents other than those highlighted.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 40 of 70