Medicinal products in Europe are under the strict control of many organisations headed by the European Directorate for the Quality of Medicines and HealthCare (EDQM) in Strasbourg and its related General European Official Medicines Control Laboratories (OMCLs) Network (GEON). The EDQM works in cooperation with the European Medicines Agency (EMA) and the World Health Organisation (WHO). All of these institutions have one main goal – to protect public health in Europe and around the world. One of the more important effects of the harmonisation of pharmaceutical law in Europe was the introduction of the mutual recognition principle for the Official Control Authority Batch Release (OCABR)/Official Batch Protocol Review (OBPR) certificates in the European Union. The National Veterinary Research Institute (NVRI) in Poland is an example of an OMCL laboratory within the Veterinary Batch Release Network (VBRN) that issues the European certificates. The NVRI is actively involved in the batch release of immunological veterinary medicinal products (IVMPs), with approximately 1,800 certificates for IVMPs issued per year. It is also one of only four veterinary OMCLs that perform Post Marketing Surveillance (PMS) studies including approximately 47 IVMPs per year. All the results of the testing data are sent to the Chief Veterinary Officer, and also to the electronic Network platforms of the EDQM, which enables transparent information exchange.
Wojciech Jerzy Pietro, Aneta Woźniak, Katarzyna Pasik, Wojciech Cybulski and Dorota Krasucka
A liquid chromatography-ultraviolet detection method for the determination of florfenicol (FF) and thiamphenicol (TAP) in feeds is presented. The method comprises the extraction of analytes from the matrix with a mixture of methanol and acetonitrile, drying of the extract, and its dissolution in phosphate buffer. The analysis was performed with a gradient programme of the mobile phase composed of acetonitrile and buffer (pH = 7.3) on a Zorbax Eclipse Plus C18 (150 × 4.6 mm, 5 μm) analytical column with UV (λ = 220 nm) detection. The analytical procedure has been successfully adopted and validated for quantitative determination of florfenicol and thiamphenicol in feed samples. Sensitivity, specificity, linearity, repeatability, and intralaboratory reproducibility were included in the validation. The mean recovery of amphenicols was 93.5% within the working range of 50-4000 mg/kg. Simultaneous determination of chloramphenicol, which is banned in the feed, was also included within the same procedure of FF and TAP stability studies. Storing the medicated feed at room temperature for up to one month decreased concentration in the investigated drugs even by 45%. These findings are relevant to successful provision of therapy to animals.