GMP für Wirkstoffe: Audit-Qualität am Bericht erkennen
Dr. Stefan Kettelhoit
blue inspection body GmbH, Münster
Manufacturing authorisation holders (MAHs) are obliged to ensure compliance with the Good Manufacturing Practices (GMP) throughout the complete process chain. According to § 11 (2) AMWHV suppliers of active pharmaceutical ingredients (APIs) and other critical raw materials/excipients must explicitly be qualified through on-site audits. The resulting audit report serves as objective evidence for the competent authority that the respective audit obligation has been fulfilled by the MAH and, moreover, that the GMP compliance status has been declared based upon comprehensible observations.
pharmind 2010, Nr. 2, Seite 242