GMP Revision May Require Audits of Raw Material Suppliers

The FDA is working on a revision to 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 probably won’t specify a frequency for the audits, Edwin Rivera-Martinez, technical vice president at Parexel Consulting and former chief of the FDA’s international compliance branch for drugs, said.

Although these audits are often conducted as part of supplier qualification, making them part of official GMP regulations is inevitable, Rivera-Martinez said. “The climate seems to be right because of the past incidents of economically motivated adulteration,” such as tainted heparin imported from China in 2008, he added.
Drug GMP Report