Alternative Microbiological Methods for Drug Quality Testing and their Implementation in Pharmacy Practice
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Pharmaceutical Chemistry Journal, Vol. 54, No. 8, November, 2020 (Russian Original Vol. 54, No. 8, August, 2020)
STRUCTURE OF CHEMICAL COMPOUNDS, METHODS OF ANALYSIS AND PROCESS CONTROL ALTERNATIVE MICROBIOLOGICAL METHODS FOR DRUG QUALITY TESTING AND THEIR IMPLEMENTATION IN PHARMACY PRACTICE M. V. Roshchina1 and O. V. Gunar1,* Translated from Khimiko-Farmatsevticheskii Zhurnal, Vol. 54, No. 8, pp. 35 – 39, August, 2020.
Original article submitted June 15, 2020. An informational-analytical review of alternative microbiological methods for quality testing of pharmaceutical products is presented. The expediency and peculiarities of implementing these methods in pharmacy practice for routine testing are considered. General approaches to validation of new methods are described. The new methods are compared with classical methods in all implementation stages. Foreign regulations on the selection of validation parameters and their acceptance criteria are analyzed. Keywords: pharmaceutical products, validation, alternative microbiological methods.
Cases of pharmaceutical products (PPs) contaminated by various bacteria and microscopic fungi were documented in the middle of the 20th century when it was also established that many preparations could act as adventitious media for microorganism development. Factual evidence that contaminants contained in medicines were hazardous for patients and were often sources of nosocomial infections was presented after several years [1]. An ill human body is weakened and lacks its inherent immunity. Therefore, administration of contaminated medicines can cause infections and serious consequences, possibly with lethal outcomes [2]. Contaminating microorganisms can affect drug components and decompose active ingredients and excipients, which can lead to a loss of therapeutic efficacy and, in certain cases, to formation of toxic products [3]. For these reasons, the quality assessment and safety of medicines available on the consumer market are some of the major challenges of the pharmaceutical industry. Sterility and microbiological purity are the most important parameters characterizing PP safety. However, microbiological analysis of PP quality is labor-intensive and can take 1
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up to 14 – 18 d. In certain instances, it cannot detect viable microorganisms (e.g., uncultured bacteria) in a sample even if the incubation time of inoculations is increased [4]. Hence, the development, validation, and implementation of new promising analytical methods into PP quality control systems is a critical problem of modern pharmaceutical science and practice [5]. Several pharmacopoeias (USA, European) [6, 7] provide for alternative analyses (rapid, accelerated) by microbiological methods in parallel with direct inoculation and membrane filtration to confirm microbiological PP quality. These alternative analyses enable more rapid, reproducible, and accurate results to be obtained. The total number of microbiological tests performed using alternative methods has significantly increased abroad in the las
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