DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)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 | 94
Drug Registration Guidance Document (<strong>DRGD</strong>)10.2.2 PARTIAL VALIDATION FOR COMPENDIAL/ PHARMACOPOEIALMETHODSTABLE X:CharacteristicsIdentificationType of Analytical MethodTesting for ImpuritiesQuantitationLimitAssay:- dissolution(measurement only)- content/ potencyPrecisionInterm. Precision √ (1)Specificity (2) √ √ √ √Detection Limit (3) √Quantitation Limit√Note:√signifies that this characteristic is normally evaluated.(1) In cases where reproducibility has been performed, intermediate precision is notneeded.(2) Lack of specificity of one analytical procedure could be compensated by othersupporting analytical procedure(s).(3) May be needed in some cases.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 95
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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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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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