DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Route of AdministrationTAMC(CFU/g or CFU/ml)Drug Registration Guidance Document (DRGD)TYMC(CFU/g or CFU/ml)Test for SpecifiedMicroorganismsVaginal Use NMT 2 x 10 2 NMT 2 x 10 1 - Absence of Staphylococcusaureus in 1g or 1ml- Absence of Pseudomonasaeruginosa in 1g or 1ml- Absence of Candida albicansin 1g or 1mlTransdermal Patches(limits for one patchincluding adhesive layerand backing)Inhalation Use (SpecialRequirement apply toliquid preparations fornebulisation)Special Ph. Eur. provisionfor oral dosage formscontaining raw materialsof natural (animal,vegetal or mineral) originfor which antimicrobialpretreatment is notfeasible and for which thecompetent authorityaccepts TAMC of the rawmaterial exceeding 10 3CFU per gram or milliliterNMT 2 x 10 2 NMT 2 x 10 1 - Absence of Staphylococcusaureus in 1 patch- Absence of Pseudomonasaeruginosa in 1 patchNMT 2 x 10 2 NMT 2 x 10 1 - Absence of Staphylococcusaureus in 1g or 1ml- Absence of Pseudomonasaeruginosa in 1g or 1ml- Absence of bile-tolerantgram-negative bacteria in 1gor 1mlNMT 2 x 10 4 NMT 2 x 10 2 - NMT 2 x 10 2 CFU of biletolerantgram- negativebacteria in 1g or 1ml- Absence of Salmonella in10g or 10ml- Absence of Escherichia coliin 1g or 1ml- Absence of Staphylococcusaureus in 1g or 1mlSpecial Ph. Eur. provisionfor herbal medicinalproducts consisting solelyof one or more herbaldrugs (whole, reduced orpowdered):National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 274