Can you demonstrate appropriate oversight of your Vendors?
Sponsors are required to have oversight of Vendors such as:
- Contract Manufacturing Organisations (CMOs)
- Clinical Research Organisations (CROs)
What do the regulations say?
Chapter 7 of EU GMP Guide requires the product owner, or contract giver, who outsources any activity covered by the GMP Guide, to define, agree and control the all outsourced manufacturing activities.
GCP requires the sponsor to retain all responsibility for the conduct and reporting of clinical trials (ICH E6(R2)).
What is in your Vendor Control Strategy?
To comply with regulation, and to ensure your product or Vendor service is fit for intended purpose it is essential to have systems and procedures in place that facilitate oversight. The basic elements of a quality management system to demonstrate appropriate oversight and vendor control very much depends on the product or service. Some elements for you to consider for your system are:
- Approved Vendor List with Vendor Qualification Status
- Vendor Selection Process
- Procedure defining the requirements for technical agreements and the transfer of technical knowledge to and from the Vendor.
- Robust Vendor Qualification Process but with flexibility to allow qualification activities to be commensurate with risk.
- Vendor Audit Process
How do you ensure appropriate Vendor Qualification and Sponsor Oversight?
We can help with training and implementation of essential elements of your vendor management system and product control strategy.
Contact us to arrange a no obligation discussion on your vendor qualification requirements (email@example.com)