Regulatory agencies expect the development and validation of a compliant cleaning program. This critical activity ensures that the risks of contamination, product carryover, and cross contamination are controlled, minimized, and monitored to safeguard patient safety and product quality.
This ISPE Guide: Cleaning Validation Lifecycle - Applications, Methods, and Controls provides a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations. Topics covered include:
Application of risk management
Adoption of a lifecycle approach for cleaning validation
Creation of cleaning validation acceptance criteria
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