Cleaning Validation for the 21st Century: Acceptance Limits for Cleaning Agents
نویسندگان
چکیده
T wo previous articles in this series discussed acceptance limits for Active Pharmaceutical ingredients (APIs) and moving to a health-based approach. This article will discuss the currently suggested approaches to setting acceptance limits for cleaning agents, some of the difficulties with these approaches, and emphasize the need to move to a health-based approach as was suggested for APIs. This discussion needs to begin with the origins of the FDA’s expectations for cleaning validation regarding detergents as cleaning agents. The assumptions, rationale, and basis and even the thought processes resulting in requirements for setting acceptance limits for cleaning agents will be reviewed. As with the articles on APIs, we need to take a historical approach and go back to the FDA’s:
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