GMP for Active Pharmaceutical Ingredients: judging the audit quality from the audit report

Manufacturing authorisation holders (MAHs) are obliged to ensure compliance with the Good Manufacturing Practices (GMP) throughout the complete process chain. Suppliers of active pharmaceutical ingredients (APIs) and other critical raw materials/excipients must be explicitly qualified through on-site audits. The resulting audit report serves as objective evidence for the competent authority that the respective audit obligation […]