blue – ISO 17020 (type A) accredited inspection body for API GMP audits

GxP audits

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.

Accreditations

Our competence, independence and neutrality is confirmed by the Deutsche Akkreditierungsstelle public authority.

GxP is an umbrella term not only for Good Manufacturing Practice, but also for various other surveillance domains. Qualified persons 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. blue inspection body can help – as your external, accredited, independent 3rd party auditor!

 

GxP 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.

Based upon our exceptional experience, knowledge and understanding we exceed customer expectations.  We handle audits of finished does drugs and all other GxP audits with the same level of professionality as well as detailed – regardless if the audit requires an accredited or non-accredited report. Our GxP service range

  • GMP of APIs
  • GMP of Excipients (incl. basic chemicals, cosmetic ingredients, disposables, etc.
  • GMP of finished dosage forms (solid, semi-solid, liquid, sterile, etc.)
  • GMP of packaging materials
  • GDP
  • GACP audits (e.g. medical cannabis)

Contact

blue inspection body GmbH
Hafenweg 18-20
48155 Muenster, Germany
Phone: +49 251 62562040

contactNOSPAM@blue-inspection.com
chinaNOSPAM@blue-inspection.com
indiaNOSPAM@blue-inspection.com

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