We will identify risk, suggest mitigating actions and monitor implementation, which will provide the organisation with a risk-based approach to implementation of compliant solutions.
11.7.2 Effective Risk Management allows the risks to be controlled to such an extent that the unwanted subset of a set of uncertain outcomes can be mitigated adequately.
11.7.4 Risk assessment plays a crucial role in not only security management, but also in ensuring delivery of consistent quality service in the healthcare supply chain. In this environment it equates to quality pharmaceutical products delivered to the correct customers, under the correct storage and transportation conditions.
11.7.5 Wholesalers should annually conduct risk assessments to assess potential risks to the quality and integrity of pharmaceutical products. The quality system should be developed and implemented to address any potential risks identified. The quality system should be reviewed and revised annually to address new risks identified during a risk assessment.
220.127.116.11 A distribution system must have in place: (d) a risk assessment programme.