DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Categories Type of Tests Specific Requirementsiii) Test for Media Sterility and GrowthPromotion Testiv) Dilution schemes for test andstandard solutions.Application of test & standardsolutions (volume, use of latinsquares, etc.)Incubation temperature & timeInterpretation of resultDetailed calculation for the testincluding ANOVA table and otherdata showing validity of testresults.Safety testsPyrogen TestBacterial EndotoxinsTest (BET) or LimulusAmebocyte Lysate(LAL) Testa. List of depyrogenated or pyrogen-freeapparatus, glassware and reagentsb. Temperature recording systemc. Retaining conditions of the animalsd. Selection of animals for teste. Preliminary test/ Sham test proceduref. Detailed test procedureg. Volume and dose of injectionh. Interpretation of test resultsa. Certificate of analysis for endotoxin andLAL (limulus amebocyte lysate) reagentb. List of depyrogenated or pyrogen-freeapparatus, glassware and reagentc. Preparation of standard solutions, LALreagent/ substrate, sampled. Detailed calculation for determination ofmaximum valid dilution (MVD)e. The product's endotoxin limitconcentration (ELC) and source ofNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 90
Drug Registration Guidance Document (<strong>DRGD</strong>)Categories Type of Tests Specific Requirementsinformationf. Detailed calculation for determination ofendotoxin limit concentration if the ELCis not in BP, USP, JP or EPg. Detailed test procedureh. Calculation and interpretation of testresultSterility Test* MicrobialContamination Testa. List of media and reagenti) Culture mediaii) List of rinsing solution, buffersolution and diluentiii) Neutralizing agent (if any)b. Preparation of media & Composition ofRinsing Bufferc. Test for Media Sterility and GrowthPromotion Testd. Preparation of test sample (includingsteps to eliminate antimicrobial activitydue to antibiotic samples or sampleswhich contain preservatives).e. Detailed test procedure for sterility testi) Quantity of sample / Volume ofsampleii) Membrane filtration / Directinoculationiii) Open System or Closed System (ifuses Membrane filtration method)iv) Volume of rinsing fluida. Preparation of mediab. Test for Growth Promoting, Inhibitoryand Indicative Properties of Mediac. Preparation of test sample (includingneutralizing of preservatives forNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 91
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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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