Abstract
The article presents the development of approaches to laboratory control and the results of research related to the standardization of methods at Ltd "BIOTESTLAB" to ensure the quality of veterinary drugs. Attention is paid to the methods of biological quality control of veterinary drugs: microbiological purity, hemagglutination reaction (HAR), determination of infectious activity of embryonic vaccines. Because such methods are characterized by low automation, low accuracy, the impact on the result of error due to personnel performing operations manually, the lack of regulatory approaches to validation of methods. The influence on the reliability of the obtained results on determining the titer of infectious activity of the virus of the following factors: quality and concentration of the applied suspension of erythrocytes of a rooster, duration of cultivation of a virus, technique of performance by the controller of each operation of a technique is investigated. Studies on the influence of these factors were conducted on the example of determining the titer of infectious activity of Newcastle disease virus. Approaches to accounting for the obtained results by the method of qualitative HAR, namely visual control of hemagglutination reaction on glass and on a plate are established. A comparative characterization of the results for the detection of hem agglutinin of Newcastle disease virus on glass (using 2% suspension of erythrocytes) and on the plate (using 1% suspension of erythrocytes). The results of inter-laboratory comparative tests of microbiological methods conducted to verify the qualification and reliability of the results are presented. It is demonstrated that the proper organization of laboratory control in measures to confirm the results of control of quantitative methods and evaluation of biological material by standardizing methods, conducting internal laboratory testing and participation in inter-laboratory comparative tests ensures and guarantees the quality of veterinary drugs.
Highlights
The article presents the development of approaches to laboratory control and the results of research related to the standardization of methods at Ltd "BIOTESTLAB" to ensure the quality of veterinary drugs
Attention is paid to the methods of biological quality control of veterinary drugs: microbiological purity, hemagglutination reaction (HAR), determination of infectious activity of embryonic vaccines
Because such methods are characterized by low automation, low accuracy, the impact on the result of error due to personnel performing operations manually, the lack of regulatory approaches to validation of methods
Summary
1, результати обліку титру інфекційної активності у якісній РГА на склі ідентичні як з 2 % так і з 5 % суспензією еритроцитів, у методиці РГА на склі визначено застосування 2 % суспензії еритроцитів півня. Також визначено параметри стандартизації методики для забезпечення щотижневого контролю біологічного матеріалу на активність вірусу хвороби Ньюкасла, що складають організацію трьох груп півнів-донорів з частотою відбору крові один раз в два тижні. Такий інтервал відбору крові при умові збалансованого раціону годування не виснажує півнівдонорів та забезпечує результати, які є більш відтворюваним, стабільними і кількісними. Наступним етапом стандартизації методики було дослідження впливу часу культивування вірусу на титр інфекційної активності Результати визначення титру інфекційної активності вірусу хвороби Ньюкасла, залежно від тривалості культивування вірусу в ембріонах (облік проведено методом якісної РГА на склі з використанням 2 % суспензії еритроцитів)
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