GxP Audit

We are happy to take over your audits in all areas of Good Manufacturing Practices (GMP) and Good Distribution Practice (GDP), whether individually on your behalf or as part of a shared audit. These include, among others:

• Active substance manufacturers in accordance with EU-GMP Part II and ICH Q7
• Manufacturers of finished medicinal products in accordance with EU-GMP Part I with all associated annexes
• Manufacturers of excipients in accordance with the guidelines for the formalised risk assessment as well as the IPEC PQG Good Manufacturing Practices Guide
• Manufacturers of primary packaging in accordance with ISO 15378
• Manufacturers of secondary packaging in accordance with GMP and ISO 9001
• Suppliers of starting materials for active substances in accordance with ICH Q7 and ISO 9001
• Transport services in accordance with EU GDP for active substances and finished medicinal products
• Commissioned laboratories in accordance with EU GMP Part I and II as well as ICH Q2, Q3, Q7 and Q14

Transparent and digital

Our aim is to make the qualification of your GMP or GDP suppliers as straightforward as possible while keeping your individual interests in mind. To this end we rely on clear reports that explain the various aspects of GMP and GDP comprehensibly and certify the conformity of the audited party. In order to satisfy not only you but also international authorities, all reports are written in English.

We place great value on 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 directly after they are produced.

Besides 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 belittle anyone. Rather, they are meant to create a basis for further development. We achieve this through maximum fairness, transparency and a detailed description and justification of the findings.