DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)ii) REQUIREMENTS FOR REGISTRATION OF VACCINES(CHEMISTRY, MANUFACTURING AND CONTROLS, CMC)A. DESCRIPTION• Description - Information on the source materials: source materials include anycomponent/ unformulated active substance used in the manufacture of theproduct (e.g microorganisms, cells/ cell subtrate, immunogen) including theirspecifications and the tests used to demonstrate compliance with thespecifications. For combination vaccines, each active substance, which will bepooled, combined with other antigens and formulated, shall be described.• Any chemical modification or conjugation of the drug substance shall bedescribed in detail.• List of inactive substances, which may be present in the drug substance.B. METHOD OF MANUFACTURE/ PRODUCTION1. Manufacturing Formula:• List of all materials (culture media, buffers, resins for peptide synthesis,chemicals, columns etc.) and their tests and specifications, or reference topharmacopoeia.• Complete formula inclusive of any adjuvants, diluents, preservatives, additives,stabilisers etc.• Production of each antigen in the vaccine (i.e. fermenter or culture volumes foreach bulk batch size as applicable and typical bulk volumes per production run).• Batch formula for each batch size and final formulated bulk product.• Lot numbering system for intermediates and final product.2. Manufacturing Process:Flow Charts/ Diagrams be Accompanied by a Descriptive Narrative:• Detailed description of manufacturing process and characterization of theproduct. Include complete history and characterization/ characteristics of eachspecies, strain, cell banking systems - Master Cell bank (MCB) and Working CellBank (WCB), cell/ seed lot system, cell substrate system, animal sources(including fertilized avian eggs), virus source or cellular sources.Ref: WHO TRS 878 (1998) Annex 1: Requirements for the use of animal cellsas in vitro substrates for the production of biologicals.• The flow chart should show the steps in production and a complete list of the in-National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 160
Drug Registration Guidance Document (DRGD)process controls and tests performed on the product at each step.• In-process holding steps, with time and temperature limits indicated.• Description of the manufacturing processes (flow diagram) in detail to supportthe consistency of manufacture of drug substance - cell growth and harvesting.• Identification of any processes or tests performed by contract manufacturers ortesters.• Animal cells: Cells of animal origin may harbour adventitious agents andconsequently pose a potentially greater risk to humans. Description of measurestaken to remove, inactivate, or prevent contamination of the product from anyadventitous agent present.• Information on measures to prevent any catastrophic events that could renderthe cell banks unusable and to ensure continuous production of vaccines iscrucial.For recombinant vaccines: description of the construction and characterization ofthe recombinant vector as well as source of master cell bank/ constructs.3. Process Validation Program:• Describe general policy for process validation and provide process validationactivities performed.4. Handling, Storage and Packaging:• All arrangements for the handling of starting materials, packaging materials, bulkand finished products, including sampling, quarantine, release and storage.C. QUALITY CONTROL1. Starting Materials:• List of all control tests performed on raw materials, with appropriatecharacterisation on starting materials.• List of raw materials meeting compendia specifications.• List of raw materials meeting in-house specifications including the testsperformed and specifications• Biological starting materials (human or animal origin) with information on therequirements to avoid risk of transmissible spongiform encephlopathies (TSEs)and human diseases (HIV, hepatitis,etc) in the final product including Certificateof Suitability (CEP). Please refer Checklist A & BRef: WHO Guidelines on Transmissible Spongiform Encephalopathies in relation toBiological and Pharmaceutical products (2010).National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 161
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PART III: NON-CLINICAL DATADrug Reg
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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