FDA GMP Revision Would Require Audits of Raw Material Suppliers

摘要

The FDA is working on a revision to good manufacturing practice (GMP) regulations that would require pharmaceutical companies to audit raw material suppliers, a former FDA official says.rnThe regulation may specify that only audits of critical suppliers are officially required and probably won't specify a frequency for the audits, Edwin Rivera-Martinez, technical VP at Parexel Consulting and former chief of CDER's international compliance branch, told WDL Nov. 5.