Risk Management in the Pharma Industry – TEVA – Free PDF download






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
Logic Diagram
Risk Management

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

Mechanical transfer
Airborne transfer.


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