What is Risk-MaPP?
Risk-MaPP provides a scientific, risk-based approach based on ICH Q9 for setting health-based cross-contamination and cleaning validation limits
These limits drive the risk controls that are implemented on a case-bycase basis to maintain product quality
Dedication / segregation always remain an option, but should not be seen as precedent-setting
Justify multi-product production in a manufacturing facility based on:
Health Based Limits
Ask the question “What Might Go Wrong?”
Evaluate each stage in the manufacturing process- be sure to include in the assessment evaluation of the manufacturing rooms, equipment and complete process
Focus on Four Possible Failure Modes
Continue at: http://www.eoq.org/fileadmin/user_upload/Documents/Congress_proceedings/Budapest__June_2011/Proceedings/15_1_morvai_slides.pdf
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