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Cleaning Validation for the 21 Century: Acceptance Limits ...

74 PHARMACEUTICAL ENGINEERING July/August 2011 Acceptance Limits for APIsThis article reviews the history of Cleaning Validation Acceptance Limits for Active Pharmaceutical Ingredients (APIs) and identifies where the currently used industry Limits came Validation for the 21st Century: Acceptance Limits for Active Pharmaceutical Ingredients (APIs): Part Iby Andy WalshIntroductionPart I of this article reviews the history of Cleaning Validation Acceptance Limits for Active Pharmaceutical Ingredients (APIs) and identifies the origins of currently used industry Limits . The current approaches to setting Acceptance Limits will be analyzed and some of the problems and weak-nesses of these approaches will be discussed.

in foods.” (Note: The phrase “Practical, Achievable, and Verifiable” began to appear in many guidelines and literature subsequently.) Harder goes on to reference 21 CFR 193 “Tolerances for Pesticides in Food Administered by the Environmental Protection Agency” and showed a table of limits for a variety of hazardous

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