Author(s)

Kunjie Wu ¹, Ruiyin Yang ¹, Xiaodong Yang ¹

Affiliation(s)

¹ Xi`an Institute for Food and Drug Control, Key Laboratory of National Medical Products Administration

Corresponding Author

Xiaodong Yang

ABSTRACT

Under the background of the new era, The United State puts forward higher requirements for the pharmaceutical industry. As one of the important indexes to evaluate the safety of drugs, the microbiological test of drugs is used to detect whether a drug is contaminated by microorganisms during the development, production and storage of the drug. The accuracy of test and measurement results is not only affected by the laboratory quality control and the expertise of the testing personnel, but also by the testing technology. Based on the comparative analysis of domestic and international drug microbiological testing methods, this study believes that in the past decades, Chinese drug microbiological testing technology has made certain breakthroughs, but compared with other developed countries, Chinese microbiological testing technology is at the initial stage, there are problems such as immature technology. In addition, Chinese microbiological testing laboratories are short of funds, relatively backward testing hardware and facilities, lack of professional testing talents, and many operations are not carried out as required. This study has certain theoretical and practical significance, which enriches the content of Chinese drug microbiological testing technology, and plays a guiding role in the innovation of Chinese drug microbiological testing method in practice.

KEYWORDS

Drug Microorganism, Comparative Analysis, Microbiological Detection

CITE THIS PAPER

Kunjie Wu, Ruiyin Yang and Xiaodong Yang, Comparative Analysis of Domestic and International Drugs Microbiological Testing Methods. MEDS Chinese Medicine (2020) Vol. 2: 1-6. DOI: http://dx.doi.org/10.23977/medcm.2020.020101.

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