DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Categories Type of Tests Specific RequirementsIdentification testsuch as color test,Fourier TransformInfrared (FTIR), ThinLayer Chromatography(TLC) etc.Impurities/degradation/ purity testAssay and uniformityof contentSpecific method for the intended analysisa. Analysis method should include:-i) Placebo solution (if any)ii) Relative retention times of impuritiesor degradation productb. Complete formula for calculationc. Method of analysis for example HPLC,TLC, etc.Specific method for the intended analysisQuality TestBiological Assay ofAntibioticsa. Procedure for preparation of followingsolutions/ substances:-i) Culture mediumii) Buffer solutionsiii) Diluentsiv) Microorganisms used in assayb. Detailed test method (diffusion orturbidimetric method), which includes:i) Preparation of standard solutions(including steps to counteract theantimicrobial properties of anypreservatives, etc present in thesample)ii) Preparation of test solutions(including any steps to neutralize theantimicrobial properties of anypreservatives, etc present in thesample)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 90
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 | 91
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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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