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Home » EC Sharpens Supplier Quality Expectations in GMP Guidelines
EC Sharpens Supplier Quality Expectations in GMP Guidelines
February 22, 2013
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.
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