DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)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 | 212