guidelines on variations to a registered pharmaceutical product

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Guidelines on Variations to a Registered Pharmaceutical Product7. Appendix 2: Changes to excipientsExcipientPercent excipient (w/w) out of total targetdosage form core weightFiller ±5.0Disintegrant• Starch• Other±3.0±1.0Binder ±0.5Lubricant• Ca or Mg Stearate• OtherGlidant• Talc• Other±0.25±1.0±1.0±0.1a) These percentages are based on the assumption that the API in theFPP is formulated to 100.0% of label/potency. The total additive effectof all excipient changes should be not more than 5.0% relative to thetarget dosage form weight (e.g. in a product consisting of API, lactose,microcrystalline cellulose and magnesium stearate, the lactose increasesby 2.5% and microcrystalline cellulose decreases by 2.5%).b) If an excipient serves multiple functions (e.g. microcrystalline cellulose asa filler and as a disintegrant), then the most conservative recommendedrange should be applied (e.g. ±1.0% for microcrystalline cellulose shouldbe applied in this example). If a wider range is proposed, scientificjustification and supporting data should be provided to demonstrate thatthe wider range will not affect the other function of the excipient.Doc. No.: DAR/GDL/005 Revision Date: 8 th July 2013 Review Due Date: 16 th July 2016Revision No.: 1 Effective Date : 16 th July 2013 Page 62 of 70
Guidelines on Variations to a Registered Pharmaceutical Product8. Literature ReferencesGuidelines on variations to a prequalified product. In: WHO Expert Committee onSpecifications for Pharmaceutical Preparations. Forty-seventh report. Geneva, WorldHealth Organization, 2013, Annex 3 (WHO Technical Report Series, No. 981).EU Guidelines on the details of the various categories of variations to the terms ofmarketing authorizations for medicinal products for human use and veterinary medicinalproducts, 12 December 2008Health Canada Post Notice of Compliance (NOC) Changes – Quality GuidanceAppendix 1 for Human Pharmaceuticals, October 17 2011Document revision historyDate ofrevisionRevisionnumberDocumentNumberAuthor(s)Changes made and reasons for revisionJuly 2006 0 Not on record Not on record First issue - Guidelines for submission ofamendments (Annex 11 of Guidelines onthe Registration of Pharmaceuticals forHuman use in Uganda.)8 th /07/2013 1 DAR/GDL/005 Eva NantongoGabriel KadduThe variation guideline has been completelyupdated and expanded, bringing it in linewith the principles of the new AuthorityPharmaceutical Product <strong>guidelines</strong>,more specifically the “Guidelines onSubmission of Documentation forMarketing Authorization of a RegisteredPharmaceutical Product for Human Use“.(Document No. DAR/GDL/005).The change categories are organizedaccording to the structure of the CommonTechnical Document (CTD) which is aharmonized electronic dossier submissionthat is acceptable internationallyDoc. No.: DAR/GDL/005 Revision Date: 8 th July 2013 Review Due Date: 16 th July 2016Revision No.: 1 Effective Date : 16 th July 2013 Page 63 of 70
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guidelines on variations to a registered pharmaceutical product

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