PROCESS VALIDATION OF EQUIPMENT PURIFICATION IN THE PRODUCTION OF ANTIBIOTICS OF CEFALOPARIN SERIES IN JV LLC JURABEK
Journal Title: World Journal of Pharmaceutical and Medical Research - Year 2019, Vol 5, Issue 2
Abstract
Currently, in practice, “Good Manufacturing Practice for Medicinal Products (GMP)” is one of the most important document defining the requirements for the production and quality control of drugs for humans and animals. This means that the condition for ensuring the quality of drugs is their production in accordance with the rules of GMP. In this regard, the development of new highly sensitive, rapid and reasonably economical methods of chemical control of the purity of the surface of pharmaceutical equipment should be considered an urgent problem. The purpose of the work was to create a complex of highly sensitive, selective and express methods of chemical control of the purity of pharmaceutical production equipment using the example of cephalosporins using chromatographic methods of analysis, as well as developing approaches to validating the cleaning process of equipment.
Authors and Affiliations
R. A. Khusainova
Keywords
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