DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)ii) CPMP/BWP/328/99. Development Pharmaceutics for Biotechnological andBiological Products - Annex to Note for Guidance on Development Pharmaceutics.iii) CHMP/BWP/157653/2007. Guideline on Development, Production, Characterisationand Specifications for Monoclonal Antibodies and Related Products.iv) EMEA/410/01 Rev. 3 Minimising the Risk of Transmitting Animal SpongiformEncephalopathy Agents via Human and Veterinary Medicinal Products.ICHi) ICH Topic Q5A Viral Safety Evaluation Of Biotechnology Products Derived FromCell Lines Of Human Or Animal Origin.ii) ICH Topic Q5B Quality of Biotechnological Products: Analysis of the ExpressionConstruct in Cell Lines used for Production of r-DNA derived Protein Products.iii) ICH Topic Q5D Quality of Biotechnological Products: Derivation andCharacterisation of Cell Substrates used for Production of Biotechnological/Biological Products.iv) ICH Topic Q5C Quality of Biotechnological products: Stability Testing ofBiotechnological/ Biological Products.v) ICH Topic Q5D Derivation and Characterisation of Cell Substrates Used forProduction of Biotechnological/ Biological Products.vi) ICH Topic Q5E Comparability of Biotechnological/ Biological Products Subject ToChanges in Their Manufacturing Process.vii) ICH Topic Q6B Specifications: Test Procedures and Acceptance Criteria forBiotechnological/ Biological Products.viii)ICH Topic Q2 Validation of Analytical Procedures: Text and Methodology.ix) ICH Topic Q8 Pharmaceutical Development.x) ICH Topic Q11 Development and Manufacture of Drug Substances (ChemicalEntities and Biotechnological/ Biological Entities).xi) ICH Topic S6 Preclinical Safety Evaluation of Biotechnology-DerivedPharmaceuticals.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 158
Drug Registration Guidance Document (DRGD)3.2.2 REQUIREMENTS FOR REGISTRATION OF BLOOD PRODUCTSNote: This document is applicable to all plasma-derived products containing an active andinactive ingredient that is derived from human blood.a) DEFINITION OF BLOOD PRODUCTAny therapeutic product derived from human blood or plasma and produced by amanufacturing process that pools multiple units.Plasma-derived therapies and their recombinant analogs are unique amongpharmaceuticals and biologics. Their production begins with a biological starting material,human plasma. Each therapy has a unique biochemical profile as a result of differences inproduction and processing methods that can lead to differing clinical responses andefficacy among patients.Hence, from the starting material, through manufacturing and final distribution to patients,the complexities of producing blood products places it in a unique class of biologics.Blood products are regulated as medicinal product. Blood products are inherently variabledue to their biological nature, and the biological methods to test them. They are subjectedto comprehensive assessment of the quality, efficacy and safety.Four (4) principal complementary approaches are adopted:• Starting material: Assurance of the quality and safety of the plasma forfractionation.• Manufacturing technique: Control of the fractionation and subsequentmanufacturing procedures for isolation, purification, viral inactivation and/or removalsteps.• Good manufacturing practice (GMP): Strict adherence to GMP. Adoption of GMPas an essential tool of Quality Assurance System.• Product Compliance: Standardization of biological methods needed incharacterisation of in-process and finished products.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 159
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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