ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Critical Step(s)

Step(s) after which a drug substance, which meets its intended characterization and impurity profile, cannot be made if there is a process malfunction or contamination. It is a step after which recovery from process malfunction or contamination is not possible.

Publication Source: ISPE Baseline® Guide, Vol. 1: Active Pharmaceutical Ingredients, Second Edition

Publication Date: 2007

Critical Step(s)

The point or points in the process which, if not carried out properly or if contaminated, will not allow drug substances to be made such that they will meet their intended characterizations and impurity profiles.

Publication Source: ISPE Baseline® Guide, Vol. 1: Bulk Pharmaceutical Chemicals
Publication Date: 1996

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