Achieving More Effective and Efficient GMP Auditing
In: Pharmaceutical Technology, Feb. 2013
Stefan Kettelhoit, blue inspection body GmbH, Muenster
Martin Van Trieste, Amgen Inc. & Rx-360
Adherence to GMP in API manufacturing is crucial in determining the safety of drug products. Due to the limitations of quality-control testing and repeatedly occurring major API adulterations, the regulations for supplier qualification have been globally tightened. As a consequence, authorities demand more vigilance of the pharmaceutical supply chain. API and other starting material manufacturers are facing an ever-increasing demand for on-site audits from their pharmaceutical customers.