DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)3.3 CHECKLISTS3.3.1 Checklist A:Products Containing Animal-Derived Materials WITH a valid TSE risk evaluationCertificate of Suitability (CEP)No. Documents Yes/ No1. TSE Risk Evaluation Certificate of Suitability (CEP)2. Basic information providing a brief description of the following:3. Rationale for using animal-derived materials4.5.6.7.8.9.Source of AnimalsDeclaration of materials of porcine originDeclaration of materials of other animal originDeclaration of the nature of the animal tissue/ parts of animalused.Description of the tissue/ organ-collection procedures andmeasures in place to avoid cross-contamination.Nature and quantity of each animal-derived material used:As a drug substance.As an excipient or adjuvant.As 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 detailsDeclaration that the final product does not contain any animalcontainingmaterials with the relevant evidence (if applicable)Other supporting documents e.g. Halal Certification of the animalderived ingredient from a competent Halal Certification Authority.10. Labelling of the animal derived materials.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 171