Responsible Person Appointment Record
Appointment record for the named individual a wholesale dealer authorisation rests on: knowledge and experience evidenced, authority listed in exercisable terms including the authority to stop a shipment, three structural independence tests, a named deputy with equivalent standing, visibility in the quality system, and change notification to the authority. Maps to EU GDP 2013/C 343/01 and MHRA GDP expectations.
What a template is not
A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.
A wholesale distribution authorisation rests on a named individual who is personally answerable for the quality system and able to stop product moving. An appointment that cannot exercise that authority is a finding about the organisation rather than about the person holding it. The structural test is the reporting line: authority routed through sales or operations places release decisions under permanent commercial pressure.
What's Inside
How to Use It
The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.
The EU GDP Guidelines 2013/C 343/01 require a wholesale distributor to designate a responsible person with defined responsibilities, the knowledge and experience the role needs, and the authority to discharge it, and MHRA GDP sets equivalent expectations for UK wholesale dealer licences. Neither prescribes the reporting line, the deputy arrangement, or what evidence proves sufficient experience in your operation — those determinations are the licence holder’s. The independence tests are SPEQ practitioner synthesis.