DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Route of AdministrationTAMC(CFU/g or CFU/ml)TYMC(CFU/g or CFU/ml)Test for SpecifiedMicroorganisms- Herbal medicinalproducts to whichboiling water is addedbefore use- Herbal medicinalproducts to whichboiling water is notadded before useNMT 2 x 10 7 NMT 2 x 10 5NMT 2 x 10 5 NMT 2 x 10 4- NMT 2 x 10 2 CFU ofEscherichia coli in 1g or 1ml- NMT 2 x 10 3 CFU of biletolerantgram- negativebacteria in 1g or 1ml- Absence of Escherichia coliin 1g or 1ml- Absence of Salmonella in10g or 10mlNotes:TAMC : Total Aerobic Microbial CountTYMC : Total Yeasts & Moulds CountNMT : Not more than(Reference: British Pharmacopoeia 2009)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 278
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 | 279
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Page 230 and 231: PART III: NON-CLINICAL DATADrug Reg
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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