DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)3.3.2 Checklist B:Products Containing Animal-Derived Materials WITHOUT a valid TSE risk evaluationCertificate of Suitability (CEP)Section Documents Yes/ No1.Detailed Assessment Report for the risk of TSE.The scope of this assessment report should include thefollowing:2. Rationale for using animal-derived materials3.Source of AnimalsDeclaration of materials of porcine originDeclaration of materials of other animal origin4. Declaration of the nature of the animal tissue/ parts used.5.6.7.8.Description of the tissue/ organ-collection procedures andmeasure in place to avoid cross-contamination.Detail of the risk factors associated with the route ofadministration and maximum therapeutic dosage of the product.Nature and quantity of each animal-derived material used:As a drug substanceAs an excipient or adjuvantAs a starting material used in the manufacture of a drugsubstance.As a starting material used in the manufacture ofexcipient.As a reagent or culture media component used inmanufacture.As a reagent or culture media component used inestablishing master cell banks.As a reagent or culture media component used inestablishing working cell banks.Others, please provide details.Relevant information to support the claim that the manufacturingprocess is capable of inactivating TSE agents.9. Certificates of analysis for each animal-derived materials used.10.Declaration that the final product does not contain any animalcontainingmaterials with the relevant evidence (if applicable)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 172
Drug Registration Guidance Document (<strong>DRGD</strong>)Section Documents Yes/ No11.Other supporting documents eg. Halal Certification of the animalderived ingredient from a competent Halal Certification Authority.12. Labelling of the animal derived materials.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 173
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Page 122 and 123: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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