Xiaoming Wang, MD. MS Manager QC Microbiology ImClone Systems A wholly -owned subsidiary of Eli-Lilly and Company USP1117 Microbiological Best Laboratory Practices USP 32 page 616 Introduction: good laboratory practices in a microbiology laboratory consist of activities that depend on several princi...
In a pharma QC microbiology laboratory, the primary objective is to identify viable microorganisms at every stage of the production process: in the air, raw materials, water and finished products. This enables lot release with the assurance of safety, efficacy and purity. To achieve this, ...
Aseptic transfer is a wide ranging term, covering the inoculation of agar tubes and plates in a microbiology laboratory to the transfer of items into a cleanroom within a sterile products manufacturing facility or a compounding pharmacy. Across the range of applications the overriding requirement is ...
• Implement systems and standards to ensure best practices and standardization with other DFP sites within processes, equipment, systems wherever possible 运用系统或标准以确保最优方法及与其他DFP工厂在工艺,仪器,系统等任何可能的方面的标准化 • Be familiar with Chinese GMPs and regulatory requirements...
In a previous article, we looked at ‘bad science’ including deliberately misleading research. Although not common, bad science still occurs. How can scientific findings be improved? We assess some best practices, In this article: what makes for good science and how what steps are being taken...
The article covers such areas as: staff practices, good system design, sanitisation methods, equipment segregation, control of tubing, point-of-use issues and the primary types of contaminants. The reference for the article is: Sandle, T. (2013). Avoiding Contamination of Water Systems,The Clini...