Adherence to Good Manufacturing Practices (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 (e.g. Heparin, Glycerol, Gentamicine), 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. Standardization and outsourcing of GMP system- or product-based audits to qualified, independent Third-parties can help to efficiently deal with these demands. The solutions presented are based on the review of current service offerings and the comprehensive audit experience of the authors. They should help paving the way for ‚less but better’ audits.

in: Pharmaceutical Technology, Feb. 2013 & in: BioPharm International, March 2013, s17-s21
Stefan Kettelhoit, Blue Inspection Body GmbH, Muenster, and Martin Van Trieste, Amgen Inc.