GxP audit
Good Manufacturing Practices (GMP) and Good Distribution Practice (GDP)
We are happy to take on your audits in all areas of Good Manufacturing Practices (GMP) and Good Distribution Practice (GDP), either individually on your behalf or as part of a shared audit. These include, among others:
- Active ingredient manufacturer according to EU GMP Part II and ICH Q7
- Manufacturers of finished medicinal products according to EU GMP Part I with all associated annexes
- Manufacturers of excipients that comply with the Guidelines for Formalized Risk Assessment to Determine Appropriate Good Manufacturing Practices for Excipients in Human Medicinal Products and the IPEC PDQ Good Manufacturing Practices Guide
- Manufacturer of primary packaging according to ISO 15378
- Manufacturer of secondary packaging according to GMP and ISO 9001
- Suppliers of starting materials for active ingredients according to ICH Q7 and ISO 9001
- Transport services in accordance with EU GDP for active ingredients and finished medicinal products
- Contract laboratories in accordance with EU GMP Parts I and II, as well as ICH Q2, Q3, Q7 and Q14
Transparent and digital
Our aim is to make your qualification of GMP or GDP suppliers as uncomplicated as possible while keeping your individual interests in mind. We rely on clear reports that explain the various aspects of GMP and GDP in a comprehensible manner and certify the conformity of the auditee. To satisfy not only you, but also international authorities, all reports are written in English.
We attach great importance to absolute transparency towards our customers.
With the help of our audit app, you can follow the entire audit process in real time.
All GMP and GDP documents created during the audit process are available to you immediately after creation.
In addition to striving to make the qualification of your supplier as simple and smooth as possible, we see it as our task to further develop your suppliers. Our findings are not intended to expose or disparage anyone. Rather, they are intended to create a basis for further development. We achieve this through maximum fairness, transparency and a detailed description and justification of the findings.
Send us your inquiry now, browse through our database or find out more on the following pages:
Here you can order your next order your next GxP audit.
