Risk-based Master Planning

CPCI has adapted ICH Q9's Risk Assessment elements to Cleaning and Cleaning Validation for developing thorough, comprehensive and Risk-based Cleaning Validation Master Plans. We don't just "round up the usual suspects" (API, Cleaning Agent and Micro/Endotoxin) - instead we ensure that all potential hazards are identified and mitigated to provide the highest degree of patient safety by starting with a Hazard Identification to look for all potential chemical and microbiological hazards presented,  the potential hazards presented by equipment and its design, and any potential failures from cleaning SOPs.

Risk-based Masterplanning flows naturally from the Hazard Identification and Risk Analysis steps to result in appropriate levels of Protocol Development. In this way the appropriate level of work, effort and documentation is applied to each situation commensurate with the level of risk.

After all hazards have been identified a Risk Analysis is performed to determine the level of Risk presented so that a Master Plan can be developed that covers all Risks with an appropriate level of effort and documentation.  After any Risk Reduction steps and a final Risk Evaluation, the Masterplanning process moves to the Risk Acceptance stage and it is at this point that the Cleaning Validation program can be vigorously defended.