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 Product4. Evidence of revalidati<strong>on</strong> studies in the case of terminally sterilized <strong>product</strong>s. The batch numbers of thebatches used in the revalidati<strong>on</strong> studies should be indicated, where applicable.5. Label artwork (in colour)Descripti<strong>on</strong> of changeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> befulfilledDocumentati<strong>on</strong>requiredReportingtype46 Change in qualitative and/or quantitative compositi<strong>on</strong> of the immediate packaging material for:46a solid FPPs 1-3 1-3 IN46b semisolid and n<strong>on</strong>-sterile liquid FPPs 1-3 1-3 Vmin46c46dSterile medicinal <strong>product</strong>s andbiological/immunological medicinal<strong>product</strong>sThe change relates <strong>to</strong> a lessprotective pack where there areassociated changes inn s<strong>to</strong>ragec<strong>on</strong>diti<strong>on</strong>s and/or reducti<strong>on</strong> in shelf lifeC<strong>on</strong>diti<strong>on</strong>s <strong>to</strong> be fulfilled1. The change does not c<strong>on</strong>cern a sterile FPP.2. No change in the packaging type and material (e.g. a different blister, but same type).VmajorVmajor3. The relevant properties of the proposed packaging are at least equivalent <strong>to</strong> those of the currentlyaccepted material.Documentati<strong>on</strong> required1. Data dem<strong>on</strong>strating the suitability of the proposed packaging material (e.g. extractable/leachabletesting, light transmissi<strong>on</strong>, permeati<strong>on</strong> testing for oxygen, carb<strong>on</strong> dioxide, moisture etc.).2. Informati<strong>on</strong> <strong>on</strong> the proposed packaging material (e.g. descripti<strong>on</strong>, materials of c<strong>on</strong>structi<strong>on</strong>,specificati<strong>on</strong>s etc.).3. Stability summary and c<strong>on</strong>clusi<strong>on</strong>s, results for a minimum of two batches of pilot or <strong>product</strong>i<strong>on</strong> scale,of three (3) m<strong>on</strong>ths of accelerated (and intermediate, as appropriate) and three (3) m<strong>on</strong>ths of l<strong>on</strong>gtermtesting and where applicable, results of pho<strong>to</strong> stability studies.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 53 of 70