WHY USE
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.
Whether it is validating a new warehouse, changing a fan in your cold room or upgrading your ERP system,
our Subject Matter Experts will guide you on the best approach and assist you with the risk rating process.
We offer the following risk mitigation strategies:
- Qualitative risk assessment – useful for approaches requiring scale-based risk ratings
- Quantitative risk assessment – useful for scenarios with data-driven risk mitigation
- Predefined risk assessments and risk mitigation templates for equipment, processes and systems
REGULATORY OVERVIEW
SAHPRA
South African Health Products Regulatory Authority
Good Wholesale Practice for Wholesalers – 2016
SAPC
South African Pharmacy Council
Good Pharmacy Practice – 2017
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.
2.3.5.4 A distribution system must have in place: (d) a risk assessment programme.