DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)2.6 STABILITY DATAStability data as shown in the following example shall be submitted for evaluation.EXAMPLE:STABILITY DATAPRODUCT NAME : TABLET ABC 500MG BATCH NO. :DOSAGE FORM : STRENGTH/ VOLUME :CONTAINER/ PACKAGING : DATE OF REPORT :MANUFACTURING DATE : dd/mm/yy TEMPERATURE : 30 °C ± 2 °CEXPIRY DATE : dd/mm/yy RELATIVE HUMIDITY : 75 % ± 5%PERIOD OF STUDY:TestsProductdescriptionAcceptance Criteria/SpecificationFilm-coated tablet,brownish in colourFrequency of Test, in month (Kekerapan Ujian, bulan)0 3 6 9 12 15 18 21 24Disintegration testNMT 30 minutesNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 270
Drug Registration Guidance Document (<strong>DRGD</strong>)TestsMicrobialContaminationTest:- Total AerobicMicrobial Count- Total Yeasts &Moulds Count- Test for SpecifiedMicroorganismsAcceptance Criteria/SpecificationNMT 2 x 10 4NMT 2 x 10 2‣ NMT 2 x 10 2 CFU ofbile-tolerant gramnegativebacteria in1g or 1ml‣ Absence ofSalmonella in 10g or10ml‣ Absence ofEscherichia coli in 1gor 1ml‣ Absence ofStaphylococcusFrequency of Test, in month (Kekerapan Ujian, bulan)0 3 6 9 12 15 18 21 24National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 271
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ATTACHMENT 1Drug Registration Guida
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Page 222 and 223: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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