DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)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 | 170
Drug Registration Guidance Document (<strong>DRGD</strong>)3. THE FINAL PRODUCT• Finished product testing and quality control• Stability study program and expiration date• Product history• Container closure system, storage and handling• Package insert and labels• Lot/ batch release protocols• Certificate of batch review and release from a competent authority4. CLINICAL STUDIES• Demonstrating product‟s efficacy5. POST MARKETING SURVEILLANCE – mandatory follow-up• Periodic Safety Update Report (PSUR)• Risk Management PlansNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 171
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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