Contract analysis and contractor auditing

Contract production and analysis become more and more important, depending upon special requirements for equipment, knowledge or personnel. The German Drug Law allows contract production and contract analysis if there is a written contract between orderer and contractor. The orderer is responsible for assessing the competence of the contract accepter. The contract must permit the orderer to audit the facilities of the contractor for compliance with the established duties. All arrangements for contract manufacture or contract analysis do not exempt the head of production or the leader of quality control of the orderer from his own responsibility. It is important to have a written contract which clearly establishes the duties of each party. The contractor has to permit the orderer to audit his facilities. Important items for a contract to be drawn up between the parties are pointed out and comments for successful quality audits are given.