FDA GMP Revision Would Require Audits of Raw Material Suppliers

November 19, 2010
The FDA is working on a revision to good manufacturing practice (GMP) regulations that would require pharmaceutical companies to audit raw material suppliers. The regulation may specify that only audits of critical suppliers are officially required, and it probably won’t specify a frequency for the audits, Edwin Rivera-Martinez, technical vice president at Parexel Consulting and former chief of CDER’s international compliance branch, said. Manufacturers would decide how frequently to audit suppliers based on their risk analyses, taking into account the relationship with the supplier and the criticality of the components.
Washington Drug Letter