DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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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 | 280
Drug Registration Guidance Document (<strong>DRGD</strong>)TestsAcceptance Criteria/SpecificationFrequency of Test, in month (Kekerapan Ujian, bulan)0 3 6 9 12 15 18 21 24Heavy Metal Test:- Lead- Arsenic- Mercury- Cadmium≤10.0 mg/kg (≤ 10ppm)≤5.0 mg/kg (≤ 5ppm)≤0.5 mg/kg (≤ 0.5ppm)≤0.3 mg/kg (≤ 0.3ppm)Conclusion ------------------------------------------------------------Prepared by: (signature) Checked by: (signature)Name:Name:Designation:Designation:Date:Date:Approved by:Name:Designation:Date:(signature)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 281
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Page 230 and 231: PART III: NON-CLINICAL DATADrug Reg
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Page 242 and 243: 1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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