Quality Agreements should be considered GMP documents. Therefore involvement of the Legal Departments can be limited. According to the latest revision of chapter 7 of the EU GMP Guide (“Outsourced activities”) ... 7.12 “A contract should be drawn up between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities and communication processes relating to the outsourced activities. Technical aspects of the contract should be drawn up by competent persons suitably knowledgeable in related outsourced activities and Good Manufacturing Practice.”
Chapter 2.7 of the revised chapter 2 of the EU GMP Guide (“Personnel”) states: “The heads of Production and Quality Control generally have some shared, or jointly exercised, responsibilities...— the approval and monitoring of contract manufacturers;”
Keeping these two chapters in mind, I would advocate for the Head of Production and Quality Control to sign a Quality Agreement. The QP must be informed, but there is no obligation for him/her to sign the Quality Agreement.
