M00002189
New product
ISPE Baseline Guide: Volume 1 - Active Pharmaceutical Ingredients (Second Edition)
Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 06/01/2007
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Availability date: 05/26/2021
Key features of the Guide include: Active Pharmaceutical Ingredient characterization Critical process steps Potential contamination Good Engineering Practice Levels of protection Critical process parameter Critical instruments Critical unit operation (new) Contamination review (new) Design qualification (new) Intended patient use (new) Direct, indirect, and no impact systems (new) Critical and non-critical components (new) Facility designation (new) Process Analytical Technologies (new) process review (new) Risk to patient (new) Understanding of process (new)
In addition, the revision of this Guide has provided the opportunity to incorporate specific current Good Manufacturing Practices (cGMP) considerations for pharmaceutical manufacturing regions outside the U.S., and has recognized and adopted harmonization work, such as the ICH (International Conference on Harmonisation) Q7 Good Manufacturing Practices for Pharmaceutical Ingredients.