How well do you know them?

Ten Questions which you need to ask yourself about your QP (Qualified Person)

  1. Are they involved enough in the changes and decisions made in your organisation ?
  2. 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 ?
  3. Does your QP have oversight of the whole  manufacturing process from API to QP release to market  of your products?
  4. 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 ?
  5. 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.
  6. 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?
  7. Do you have a current CV for your QP? Is your organisational chart current ?
  8. How do you check the QPs competent and Do you ever check their CPD ?
  9. Does your Regulatory Affairs department keep the QP up to date with any variations they have submitted or changes which they may be planning ?
  10. Do you have a disaster plan and a succession plan for your QP?