DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)4. Tests for Microbial Contamination, as shown in Table 15 below:Route of AdministrationNon-aqueous preparations for oraluseTAMC(CFU/g or CFU/ml)TYMC(CFU/g or CFU/ml)Specified micro-organisms10 3 10 2 Absence of Escherichia coli (1 g or 1 ml)10 2 10 1Aqueous preparations for oral use 10 2 10 1 Absence of Escherichia coli (1 g or 1 ml)Absence of Burkholderia cepacia (1 g or 1 ml)Oromucosal useml)Absence of Pseudomonas aeruginosa (1 g orAbsence of Staphylococcus aureus (1 g or 11 ml)Absence of Burkholderia cepacia (1 g or 1 ml)Special Ph. Eur. provision for oraldosage forms containing rawmaterials of natural (animal,vegetal or mineral) origin for whichantimicrobial pretreatment is notfeasible and for which thecompetent authority acceptsTAMC of the raw materialexceeding 10 3 CFU per gram orper millilitre10 4 10 2 Not more than 10 2 CFU of bile-tolerant gramnegativebacteria (1 g or 1 ml)Absence of Salmonella (10 g or 10 ml)Absence of Staphylococcus aureus (1 g or 1ml)Absence of Burkholderia cepacia (1 g or 1 ml)– for aqueous preparation onlySpecial Ph. Eur provision forherbal medicinal productsconsisting solely of one or moreherbal drugs (whole, reduced andpowdered):- herbal medicinal products towhich boiling water is addedbefore use- herbal medicinal products towhich boiling water is not addedbefore useNot more than 10 2 CFU of Escherichia coli (110 710 5g or 1 ml)Not more than 10 3 CFU of bile-tolerant gramnegativebacteria (1 g or 1 ml)Absence of Escherichia coli (1 g or 1 ml)Absence of Salmonella (10 g or 10 ml)Notes:- Abbreviation:TAMC : Total Aerobic Microbial CountTYMC : Total Yeasts & Moulds CountNMT : Not more than- Interpretation of the results as follows:10 1 CFU : maximum acceptable count = 20;10 2 CFU : maximum acceptable count = 200;10 3 CFU : maximum acceptable count = 2000, and so forth.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 218
Drug Registration Guidance Document (<strong>DRGD</strong>)Specifications and Certificate of Analysis of Active IngredientCertificate of analysis for each active ingredient (raw material) is required preregistration.The certificate must consist of specifications and results of analyses.Other Supporting documents‣ For the submission of other supporting documents.‣ Additional requirement for safety and quality of active ingredient/ product (e.g.;dose for children, pregnant etc.)‣ Quality testing for specific ingredient:- For product containing Aphanizomenon flos-aquae, applicants wouldhave to provide certificates of analysis showing that the microcystin-LR ortotal microcystins content of the raw material does not exceed 1μg/g andthe finished product has been tested for microcystin-LR using anacceptable method‣ Quality testing for specific product:- Certificate of Analysis for Dioxin level is required for product containingingredient(s) derived from seafood- Certificate of Analysis for proof of hormone-free is required for productcontaining placentaNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 219
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Page 168 and 169: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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Page 238 and 239: 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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