13.1 Is there a written procedure for selection and use of contractors for handling of pharmaceutical starting materials?

13.2 Does this procedure include safety and quality criteria for the selection of contractors?

13.3 If a sub distributor is supplied, are they signatories to a Responsible Care or Responsible Distribution program?

13.4 Does this procedure include performance evaluation of these contractors?

13.5 Are contract acceptors evaluated to comply with GTDP principles prior to entering into the contract?

13.6 Are contract acceptors periodically re-evaluated according to GTDP principles?

13.7 Are contracts specifying the distribution of GTDP related task between contract giver and contract acceptor?

13.8 Is sub-contracting prohibited unless specific controls are performed?