Are your consultants listed on your approved vendor list?
A company recently received this 483 observation:
…..Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been adequately established.
Specifically, your Vendor Qualification and Monitoring procedure, as well as Vendor Auditing procedures, do not define the type and extent of control to be exercised over your quality system consultants. During review of your quality system records, I observed that two different consultants, contracted to either conduct internal or supplier audits, have not been evaluated and approved. The consultants include:
a. ….. – Quality Assurance and Regulatory Affairs Consultant, whom on behalf of your company did audit two different suppliers.
b. ….. – Quality Management Consultant, audited your quality system as part of your internal audit activity.
These consultants have not been evaluated and selected based on their ability to meet your specified quality requirements. The consultants are not listed on your Vendor Log/Approved Supplier List (ASL), and you could not provide evaluation, approval or monitoring records when requested. .
For more observations pertaining to laboratory controls see Issue 1023 available today. It also has observations pertaining to manufacturing controls, active pharmaceutical controls and sterile manufacturing controls.