DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)10. GUIDELINE FOR THE SUBMISSION OF ANALYTICALMETHOD VALIDATION (AMV) DOCUMENTS10.1 TYPES OF ANALYTICAL PROCEDURES TO BE VALIDATEDa) Identification testsb) Quantitative tests for impurities' contentc) Limit tests for control of impuritiesd) Quantitative tests of the active ingredient in the sample (assay and dissolution)e) Pyrogen or Bacterial endotoxin testf) Sterility testg) Microbial Contamination Testh) Biological Assay of Antibiotics10.2 TYPICAL VALIDATION PARAMETERS FOR CHEMICAL TESTS10.2.1 FULL VALIDATION FOR IN-HOUSE METHODSPlease refer to Table IX on next page.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 94
Drug Registration Guidance Document (DRGD)TABLE IX:Type of Analytical MethodCharacteristicsIdentificationTesting for ImpuritiesQuantitationLimitAssay:- dissolution(measurement only)- content/ potencyAccuracy √ √PrecisionRepeatabilityInterm. Precision√√ (1)√√ (1)Specificity (2)Detection LimitQuantitation Limit√ √ √ √(3) √√LinearityRange√√√√National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 95
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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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