GMP audits and API inspections
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:
- Individual third-party GMP audits or API audits of your suppliers
- Pooled API audits (several individual audits bundled into one audit trip)
- Shared third-party audit (GMP audit of one manufacturer for several clients at the same time)
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 together – in the form of a shared third-party audit. In order to conduct accredited API audits we make use of the inspectors of blue inspection body GmbH.
We have already carried out numerous inspections of manufacturers who produce a large number of APIs to determine if the APIs are being manufactured in compliance with GMP guidelines. We offer current GMP audit reports that are specific to APIs and manufacturers for purchase. >> read more
