EC Sharpens Supplier Quality Expectations in GMP Guidelines

The European Commission (EC) is urging drugmakers to discuss quality requirements with suppliers and document agreed-to controls in a quality accord, according to revised GMP guidelines. Such agreements should also describe each business partner’s role and responsibility in identifying and reporting defective finished products and implementing risk-reducing actions. Manufacturing authorization holders have a “legal obligation” to ensure that active substances are produced in accordance with GMP, the commission cautioned last month.
Drug GMP Report