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ISPE Expands Commissioning and Qualification Guidance Series

New guide bridges gap between Baseline Guide and full ICH Q8, Q9, Q10 adaptation

ISPE

ISPE

Mon, 12/12/2011 - 09:15
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(ISPE: Tampa, FL) -- The International Society for Pharmaceutical Engineering (ISPE), a global nonprofit association of 22,000 pharmaceutical science and manufacturing professionals, has released a new guidance document on pharmaceutical commissioning and qualification titled, ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification. This new guide successfully provides a bridge between the baseline strategies outlined in the ISPE Baseline Guide, Volume 5: Commissioning and Qualification and the more advanced strategies prescribed in the ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment.

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