DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Plasma for fractionation and blood products that are regulated by National PharmaceuticalControl Bureau (NPCB) includes:• Plasma products derived from plasma collected and fractionated in Malaysia for usein Malaysia;• Plasma products derived from plasma collected and fractionated overseas for use inMalaysia; and• Plasma products derived from overseas-sourced plasma fractionated in Malaysia foruse overseas.b) REQUIREMENTS FOR REGISTRATION OF BLOOD PRODUCTS1. QUALITY OF PLASMA SOURCE MATERIALPlasma Master File (PMF). It can also be a stand-alone document. Documentpertaining to the collection and controls of source materials. Key elements of PMFare:• Requirements for a formal contract governing purchase and supply of plasma.• Source plasma.• GMP status of the blood establishments/ collection centers.• Description of the quality assurance system applying to plasma supply anduse.• Arrangements for donor selection, selection/exclusion criteria.• Data on population epidemiology and blood-borne infections.• Requirements for testing of samples of donations and pools. Mandatoryserology on all plasma donations. Each unit of source material tested forHBsAg, anti-HIV and anti-HCV• Plasma bags, plasma quality and plasma specifications.• Arrangement for communication and review of post-donation information.• Plasma inventory hold.• Traceability from donor to end product and vice versa.Ref: CHMP/BWP/3794/03 Rev. 1 Scientific data Requirements for Plasma MasterFile (PMF) and also the checklist.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 166
Drug Registration Guidance Document (DRGD)2. MANUFACTURING PROCESS AND CONTROLDocuments that verify each batch of source material intended for manufacture hasbeen serological tested for hepatitis B (HBV), hepatitis C (HCV) and HIV. Eachbatch of source material must also be tested for HCV RNA by Nucleic Acid Testing(NAT) and (increasingly for other viruses including HIV, HBV, B19, and HAV) andexclusion of reactive donations.Characterization: Physicochemical and biological characterization: Specific teststhat will provide information regarding identity, purity, potency, stability andconsistency of manufacture for the drug substance.Manufacture and Controls:i) Formula:• Include a list of all starting materials, reagents, monoclonal antibodies,intermediate products and auxiliary materials (buffers, sera, antibiotics etc.)with specifications or statement of quality for each.• Excipients: List of excipients.• For non-compendial excipients: Describe tests and specifications.• For novel excipients: Include description for preparation, characterisation andcontrols.• When used as excipient in the product, the expiry date of the plasma-derivedproduct should not be earlier than that of the finished product.ii) Manufacturing:• Detailed description of manufacturing process and controls to demonstrateproper quality control or prevention of possible contamination with adventitiousagents.• In-process and final controls.Viral inactivation and/ or removal processesViral validation studies and reportPathogen safety document inclusive of Transmissible SpongiformEncephalopathies (TSEs) risk assessmentInformation or certification supporting the freedom of reagents, inactiveingredients of human or animal origin from adventitious agents.Process consistencyAnalytical validation studiesProcess validation studies (purification, sterility etc.)Batch record and batch release specificationsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 167
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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