With the same diligence as for APIs, blue inspection body also audits excipients.
On behalf of our clients we examine whether excipients meet GMP requirements.
This section provides a summary listing of FAQ addressing the various aspects of services offered by the blue inspection body GmbH.
Does blue audit manufacturers of critical excipients for medicinal products?
blue inspection body GmbH is accredited for “audits of manufacturers of starting materials and active ingredients for pharmaceutical products and for verification of compliance with the international GMP regulations“. In view of the above, we also conduct GMP audits of manufacturers of excipients.
What advantages does an accredited audit report offer to the client?
Audits of manufacturers of pharmaceutical active ingredients and excipients may be conducted by authorized in-house qualified staff members or by a contracted external entity. In the latter case, competence, quality and autonomy of the contracted auditors must be verified. These very issues are reflected in blue's quality management system and form part of accreditation as an inspection body. This allows for a less cumbersome verification by our clients. Moreover, our procedures are standardised and transparent, i.e. all processes pertaining to our third-party audits are reproducible and documented; the documents and notes of conducted audits are archived in their entirety ( and of course by safeguarding confidentiality). The processess are subject to annual surveillance by the accreditor. Further worthy of note are our high quality standards and a large number of conducted GxP audits. This ensures professional preparation and conduct of an audit as well as a conclusive audit report.
What is meant by “autonomy“?
blue inspection body GmbH is a “type A“ inspection body, which signifies the highest level of autonomy. Specifically, there are no direct or indirect business connections between the inspected companies and blue. At the same time, the appointed blue GMP inspector must rule out in writing any prior business connection, major shareholding (direct or indirect) and subsequent engagement with the inspected company for every accredited third-party audit.
How much does a third-party audit usually cost?
Costs associated with an accredited GMP audit depend on the scope of the audit, and are specified in our fee schedule.
On what body of rules rests a GMP audit by blue?
Audits are conducted based on Guideline ICH Q7, which corresponds to part 1 of the EU GMP Guide. Moreover, additional applicable laws, regulations, GMP guidelines and standards such as the AMWHV, part 1 of the EU GMP Guide as well as monographs of pharmacopoeia (USP, EP, etc.) are observed.
What education and professional experience does a blue GxP auditor have?
Qualification requirements for auditors and lead auditors are specified in the quality management system of blue inspection body GmbH, and they are in line with the international standards. In addition to formal education in life sciences (usually pharmacy), every GxP auditor possesses several years' experience in the industry and has additional training and/or relevant extensive experience which qualify him/her as a GxP auditor.