论文信息 - Quality Risk Management of Microbial Burden in Parenteral API Production Processes

Quality Risk Management of Microbial Burden in Parenteral API Production Processes

This paper describes a risk assessment technique that may be used to control bioburden in parenteral active pharmaceutical ingredient (API) production processes. Readers can use the risk assessment technique to achieve bioburden control during API processing. The objective in creating this tool was to develop a way to establish a balanced control strategy regarding bioburden.

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