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UK QPCOP (Pre-req to duties (contract QP (contract (confusion on resp of…

- - - - ensure alligned position
    - - notify SLT
      - Contact JPB or reg auth to advise
    - - notify SLT
  - - - Their role to QP
      - ensure they understand QP legal role/resp
  - - - remote QP certification must be defined in PQS
  - - - confusion on resp of QP-company?
        
        Contact local inspector
        
        Quality issue notification to QP when off site
- - - - go to professional body
        
        contact with experienced QP
- - - - audits/disciplinary action
      - lack knowledge/exp in product = refuse certification
      - EU GMP chap 1 (QMS - GMP, MA, QRM, resourced, SLT resp, support at all levels in supply chain)
      - share COP with SLT
- - - - but UK COP requires more technical/ethical/professional obligations - and UK COP is to be followed by Law - so basically legally enforceable.
      - Legal duties of QP specified
    - - professional duty to refuse certification of products IF you don;t have practical exp
- - - - Approved by SMEs
    - - additional sampling/testing?
    - - see A16 for guidance on QP duties
    - - amount direct resp QP takes
        
        A16 duties , Delegated in PQS?
        
        ensure they must understand QP resp
        
        ensure assurance task done correctly
        
        MUST HAVE OVERSIGHT OF PQS ASSURED ITS EFFECTIVE
      - Multiple QPs in supply chain
        
        QPQP/QTA contract to split responsibility
- - - - giver gives info to acc (MA)
    - - no MIA?
        
        named on giver MIA