ISPE Releases New Guidance on Pharmaceutical Commissioning & Qualification
The new guidance describes how firms can move from established baseline practice to a more efficient science- and risk-based framework.
The International Society for Pharmaceutical Engineering (ISPE) has released new guidance on pharmaceutical commissioning and qualification.
The document, ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification, bridges the basic strategies outlined in the ISPE Baseline Guide, Volume 5: Commissioning and Qualification and the more advanced strategies described in the ISPE Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment.
The new guidance describes how firms can move from established baseline practice to a more efficient science- and risk-based framework. It illustrates the application of Quality Risk Management to traditional commissioning and qualification practi
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