Privatsphäre-Einstellungen

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.
The following article covers necessary requirements for API audit reports aiming to demonstrate that the GMP status of a supplier has been reasonably and comprehensibly assessed during the onsite audit. Based upon the EMEA “GMP Inspection Report – Community Format” a proposal has been developed for the unambiguous, understandable and most importantly complete coverage of audit contents in the audit report.