How well do you know them?
Ten Questions which you need to ask yourself about your QP (Qualified Person)
- Are they involved enough in the changes and decisions made in your organisation ?
- Do they report to the decision makers ? Can they easily communicate with the decision makers ? Is there an escalation process in place which is responsive and effective ?
- Does your QP have oversight of the whole manufacturing process from API to QP release to market of your products?
- Does the QP work closely with your Responsible Person (RP ) ? Is the QP your RP also ? If this is the case is this a risk to your organisation ?
- Do you involve your QP in the qualification of vendors and the development of your Quality agreements with them ? how well do they communicate with other vendors.
- If you have more than one QP, are their roles the same or do you have “Inter- QP “Quality agreements and different roles and responsibilities?
- Do you have a current CV for your QP? Is your organisational chart current ?
- How do you check the QPs competent and Do you ever check their CPD ?
- Does your Regulatory Affairs department keep the QP up to date with any variations they have submitted or changes which they may be planning ?
- Do you have a disaster plan and a succession plan for your QP?