(2003; 148 pages)
7.11 There must be a written contract between the contract giver and the contract accepter which clearly establishes the responsibilities of each party.
7.12 The contract must clearly state the way in which the authorized person, in releasing each batch of product for sale or issuing the certificate of analysis, exercises his or her full responsibility and ensures that each batch has been manufactured in, and checked for, compliance with the requirements of the marketing authorization.
7.13 Technical aspects of the contract should be drawn up by competent persons suitably knowledgeable in pharmaceutical technology, analysis and GMP.
7.14 All arrangements for production and analysis must be in accordance with the marketing authorization and agreed by both parties.
7.15 The contract should describe clearly who is responsible for purchasing, testing and releasing materials and for undertaking production and quality controls, including in-process controls, and who has responsibility for sampling and analysis. In the case of contract analysis, the contract should state whether or not the contract accepter should take samples at the premises of the manufacturer.
7.16 Manufacturing, analytical, distribution records and reference samples should be kept by, or be available to, the contract giver. Any records relevant to assessing the quality of a product in the event of complaints or a suspected defect must be accessible and specified in the defect/recall procedures of the contract giver.
7.17 The contract should describe the handling of starting materials, intermediate and bulk products and finished products if they are rejected. It should also describe the procedure to be followed if the contract analysis shows that the tested product must be rejected.