GMP Audit

GMP audits on contract, worldwide and accredited 3rd party API audit reports: Diapharm checks whether contract manufacturers and active ingredient suppliers are adhering to GMP / ICH Q7 standards.

GMP audit services

Marketing authorisation holders are required to qualify their contract manufacturers and API suppliers according to GMP standards. We carry out the necessary audits for pharmaceutical companies worldwide.

Our GMP audit service gives you:

• Exclusive / non-exclusive GMP audits and API-GMP audits
• Coordination of the performance of independent and high-quality third-party audits
• On-site attendance at audits by appropriate interpreters
• Comprehensive audit report with full auditing in accordance with ICH Q7 (35 – 70 pages)
• Management of deviations (CAPA assessment and response)
• All costs (travel expenses, meals, etc.) included in the price (excluding VAT)

Ready-made API GMP audit reports

We have already performed inspections of active pharmaceutical ingredients from numerous manufacturers around the world to determine whether their APIs are being manufactured in compliance with cGMP guidelines. Many of these audit reports are available for purchase: www.diapharm.com/english/audit-report.html

All reports are subject to signed and valid confidentiality agreements with the audited companies. Distribution of an audit report is therefore related to prior approval by the respective company.

For more information visit www.diapharm.com