The Danish Medicines Agency (DMA) has published a document entitled: The Danish Medicines Agency's expectations for audits of API manufacturers.
The Qualified Person must make sure that APIs are manufactured in compliance with the requirements laid down in the EU GMP Guide Part 2 (ICH Q7). The task of the qualification of API manufacturers can be delegated to sufficiently qualified staff.
The DMA defined a number of expectations which need to be fulfilled if the QP delegates the task to a third party. The following extracts are taken and shortened from the document
The following information regarding the Auditors should be available
2) Audit Report
An audit should cover all processes relevant to the manufacture and handling of the API concerned. In subsequent audits of an API manufacturer, the focus should be on the other areas than those focused on in the previous audit.
The following information should be part of the Audit report:
Based on the information provided above, a system-based audit would certainly not comply with the DMA requirements. Therefore, product specific audits are necessary to qualify an API manufacturer.
In the assessment of an API manufacturer (documented by the QP), the following must be considered:
It is also important to conclude from data if the API manufacturer found to be GMP compliant.
4) Ongoing Assessment
The Agency also expects that the manufacturer of the medicinal products performs a risk assessment whenever a CEP is withdrawn or a GMP Inspectorates issues a statement of non-compliance.
Source: The Danish Medicines Agency