DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Categories Type of Tests Specific Requirementssamples that contain preservatives)d. Total Viable Aerobic CountDetailed test procedure for TotalAerobic Microbial Count TAMC) andTotal Yeasts and Moulds Count(TYMC) by Plate Count, MembraneFiltration or Most-Probable Number(MPN) method.e. Test for Specified MicroorganismsDetailed test procedure for eachspecific microorganism tested(including identification andconfirmation test)Specification and acceptancecriteriaFor details, please refer circular Bil(4) dlm. BPFK/PKK/12/05Mycrocystin test For a product containingAphanizomenonflosaquae, applicantswould have to provide certificates ofanalysis showing that the microcystin-LR ortotal microcystins content of the rawmaterial does not exceed 1μg/g and thefinished product has been tested formicrocystin-LR using an acceptablemethod* Note:Manufacturer shall ensure that products manufactured locally or overseas are free fromany contamination of Burkholderia Cepacia. Please refer to these circulars for details:Pekeliling Ujian Burkholderia cepacia.pdfPekeliling Ujian Kontaminasi Burkholderia cepaciaNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 92
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 | 93
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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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Route of AdministrationTAMC(CFU/g o
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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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