As a manufacturer or sponsor of a pharmaceutical and/or medical device, you need to ensure control over component and product quality, as well compliance with legal and customer requirements. Establishing and maintaining a supplier quality assurance program can be a challenge, with regulatory requirements and supply chain complexity continuing to increase.
In our experience, the companies that have a good handle on their supply chain employ the following 6-step quality assurance strategy:
- Planning
- Selection of Potential Suppliers
- Evaluation and Acceptance
- Establishing Controls
- Delivery, Measurement and Monitoring
- Feedback and Communication
This framework allows companies to minimise risk and provides them the platform to ensure they are compliant to GMP regulations set by the TGA, FDA and EMA for example.
Implementing the quality assurance plan requires an intimate understanding of the current regulatory requirements, along with appropriate SOPs and documentation underpinned by your Supplier Quality Agreement(s).
Contact us if you’d like assistance in any of these areas, or you may be interested in our Supplier QA training course.
