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

Neutral and Independent

Accreditation as an inspection body is an important quality criterion for those commissioning third party audits. It ensures that a GMP inspection is impartial and is performed to a high standard of quality, reliability and efficiency.

ISO 17020 (type A)

Our competence, independence and neutrality is confirmed by public authorities acc. to ISO 17020 (type A).

ISO 17021

blue is accredited acc. to ISO / IEC 17021 to inspect and certify ISO 9001 compliance

"Certification of competence in a specified subject or areas of expertise, and of the integrity of an agency, firm, group, or person, awarded by a duly recognized and respected accrediting organization.” 

Our Accreditation is an internationally acknowledged seal of approval. It distinguishes the excellence of our quality management systems, the competence of our auditors and the conformity of our audit reports with international standards.

As the first service provider in the European Union, blue inspection body has been accredited since 2007 for performing independent GMP audits of APIs and excipients. The German accreditation body DAkkS is constantly monitoring our competence, expertise and integrity in performing these audits.

The benefits for you are:

  • Internationally  accepted audit reports
  • Highest level of independence and confidentiality
  • Highly qualified auditors with long standing experience and annual trainings
  • Standardised, transparent audit procedures
  • Quality management based inspection body  - unique for GxP audits
  • Globally delivered service with the main focus on pharma
  • Continuous maintenance of quality level due to regular monitoring by DAkkS

Complaints and appeals handling

We have established documented procedures for handling complaints. The Complaint Review Board (CRB) of the blue inspection body is responsible for handling complaints. Within three weeks of receipt of a complaint, the complainant receives written confirmation of receipt. Please provide the full address, name and contact details via the contact field on the website. The complaint will be processed and closed within a reasonable time after the confirmation of receipt has been sent.

Competence and independence

Authorities make third party audits subject to a number of conditions: the drug manufacturer must for example ensure that auditors have the requisite professional expertise and independence. Our current processes for granting, refusing and maintaining certification or extending or restricting the scope of certification can be found here. We provide further documents upon request under the following link.

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

This website uses cookies

We use cookies to improve the user experience. By continuing to use this website, you consent to the use of cookies.