Microbial contamination of veterinary medicaments and drugs in the Czech Republic 1993 to 1996

Veterinarni Medicina 43, 1998, 213-217

A survey of results of microbiological quality control of veterinary pharmaceutical preparations were checked up in the Institute for State Control of Veterinary Biologicals and Medicaments in Brno from 1993 to 1996 is given. The basic aim was to suggest new limits for Pharmacopoea Bohemica 1997 including the total count of micro-organisms in the category Pulveres praemixti pro usu veterinario and to incorporate specified veterinary preparations in the strict category of microbial quality. For this aim, it was necessary to carry out the quality control of these preparations and to carry out the monitoring of the occurrence of micro-organism species. The practical result was the elimination of preparations containing pathogenic, opportune pathogenic or toxicogenic micro-organisms and/or the elimination of preparations containing an amount of micro-organisms larger than is admissible. A review of literature especially includes the comparisons of views on the evaluation of microbial quality control by current Pharmacopoeia Bohemoslovaca 1987 and current European Pharmacopoeia 1997. In this study, the obligatory method for microbiological quality control of pharmaceutical preparations in the Czech Republic, which proceeds from Pharmacopoeia Bohemoslovaca 1987 and its Addendum 1991, and from other microbiological methods especially European Pharmacopoeia 1997 and the standardised methods of Czech Norms ISO, was followed. The computer image analysis was used for the identification of micromycetes and colony counting. The results are based on the examination of the total 651 samples, 260 samples were examined for sterility and 391 for microbial contamination. In the category Test for Sterility the total of 3.85% and in the category Microbial Contamination Tests the total of 8.70% preparations did not comply with this criteria. In this examination 227 strains from 16 genera and 26 species of bacteria and 96 strains from 10 genera and 15 species of micromycetes, were isolated. The conclusions are limits and changes which were advanced as a suggestion to Pharmacopoeia Commission for the assessment and approval into new Pharmacopoeia Bohemica 1997

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