ISPE Guide: Cleaning Validation Lifecycle – Applications, Methods, & Controls PDF

Regulatory agencies expect the development and validation of a compliant cleaning program. This critical activity ensures that the risks of contamination, product carry over, and cross contamination is controlled, minimized, and monitored to safeguard patient safety and product quality.

This ISPE Baseline Guide: Cleaning Validation Lifecycle: Applications, Methods, and Controls provide 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
• Cleaning methodologies
• Creation of cleaning validation acceptance criteria
• Determination of visual inspection limits
• Calculation and justification of residue limits
• Validation of testing and sampling methods
• Equipment issues and challenges
• Change Management