Articles by Stefan Kettelhoit - Pharmaceutical Technology

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Articles by Stefan Kettelhoit

Achieving More Effective and Efficient GMP Auditing

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.
Feb 1, 2013

Adherence to GMP in API manufacturing is crucial in determining the safety of drug products.


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