GxP / GMP Audits

The abbreviation “GxP“ combines guidelines for “good working practices“ pertaining to various branches of the pharmaceutical industry. Manufacture of medicinal products is at the very core of GxP. It is governed by the fundamental principles of Good Manufacturing Practice (GMP) which serve to ensure quality, efficacy and safety of medicinal products.

We ease the burden of your workload during planning and conduct of your GxP/GMP audit, create detailed and product-specific audit reports based on current guidelines and your individual specifications in a timely manner and, last but not least, monitor the initiation of any potentially required corrective actions. In addition, we offer support during preparation for a re-audit.

GMP audits

GMP auditing of manufacturers of active substances is a precondition for approval and batch release of medicinal products. We offer the required high-quality GMP compliance audits: Blue Inspection Body monitors Good Manufacturing Practice of manufacturers of active substances, excipients and finished medicinal products, as well as of manufacturers of primary and secondary packaging materials worldwide:

GxP audits

Particularly the small and medium-sized companies tend to hit resource bottlenecks due to increasing GxP audit obligations. Staff-intensive, time-consuming and costly audits, which are usually associated with enormous travel requirements, can hardly be efficiently managed by the in-house staff. GxP is an umbrella term not only for Good Manufacturing Practice, but also for various other surveillance domains such as: