(2003; 148 pages)
Suppliers’ audits and approval
8.8 The person responsible for quality control should have responsibility together with other relevant departments for approving suppliers who can reliably supply starting and packaging materials that meet established specifications.
8.9 Before suppliers are approved and included in the approved supplier’s list or specifications, they should be evaluated. The evaluation should take into account a supplier’s history and the nature of the materials to be supplied. If an audit is required, it should determine the supplier’s ability to conform with GMP standards.