GMP audits and API inspections (3rd party audits)
GMP audits on contract, worldwide: We check whether active ingredient suppliers and contract manufacturers are adhering to ICH Q7 standards. We also offer accredited API audit reports for purchase.Diapharm’s GMP audit service gives you:
- Exclusive / non-exclusive GMP audits or API 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)
As a marketing authorisation holder, you are required to qualify the suppliers of your active pharmaceutical ingredients (API) using GMP audits of their facilities. Due to the fact that API manufacturers are often suppliers to a number of pharmaceutical companies, it is logical to conduct the required GMP audits in the form of a 3rd-party audit. In order to conduct accredited API audits we make use of the inspectors of blue inspection body GmbH.
We have already performed inspections of active pharmaceutical ingredients from numerous manufacturers around the world to determine whether the APIs are being manufactured in compliance with GMP guidelines. Further information and a list of available API GMP audit reports can be found >> here
