Raport privind rezultatele testului de competentă a laboratoarelor pentru determinarea nivelului de microorganisme din produsele farmaceutice

Abstract

The present study describes the results obtained by the Microbiological Control Laboratory from Institute for Control of Biological Products and Veterinary Medicines after participating in the proficiency testing scheme study on low – level microbial enumeration from pharmaceutical products. The proficiency testing scheme was organized by LGC Standards, Great Britain, organisation with competences in managing of the proficiency testing scheme for laboratories. Membrane filtration is a microbiological technique used for the microbial enumeration test, which consist in the transfer of the appropriate amounts from the sample, prepared according to the provisions of the European Pharmacopoea, through a membrane filter, incubating it on appropriate culture media, followed by reading and interpretation of the results. The result obtained by the Microbiological Control Laboratory was 34 CFU/vial, and the value attributed by LGC Standards was 30 CFU/vial.The Z- scores were 0,16 and the performance of Microbiological Control Laboratory was very good for low –level microbial enumeration from sample