Skip to main content

Quality - Our Values Statement

The pharmaceutical industry relies on ensuring the quality and safety of its products.

It is therefore our responsibility to our clients and auditees alike to perform our services accurately, efficiently and with the highest level of integrity.

Our commitment to implement this standard is reinforced by the framework of our accreditation.    

We have chosen to organise and perform audits as an ISO 17020 accredited company, fostering trust and independence while prioritising quality in all our work.

Accreditation

The audit services of blue inspection are designed to meet the highest standards. Our goal is to contribute to the safety of medicines through high-quality audit reports and to maximize the efficiency of cooperation between pharmaceutical manufacturers and their suppliers. In order to ensure a consistent quality in our audit services, blue inspection has opted for accreditation in accordance with DIN EN ISO/IEC 17020:2012-07. Under this international standard, blue inspection is accredited as a third-party auditing company for inspections of excipient and active pharmaceutical ingredient manufacturers for pharmaceutical products and for determination of the conformance with international GMP rules. The accreditation is granted by the official German accreditation body (DAkkS). The validity of blue’s accreditation certificate can be verified on the website of the DAkkS.

The official accreditation by the German accreditation body DAkkS proves the independence, and impartiality of our third-party-audits. During regular inspections, the DAkkS monitors our quality management system and the quality of our audit services. Furthermore, audit performance on-site is regularly monitored by experts (official GMP inspectors from German authorities) on behalf of the DAkkS.

Quality Management

blue inspection’s quality management system according to ISO/IEC 17020 covers the following aspects:
• Quality Manual / Quality Policy
• Regular internal audits / self-inspections
• Control of documents and records
• Change Control
• Deviation Management / CAPA Management
• Management of complaints
• Regular management reviews
• Regular training of employees / auditors
• Written procedures for qualification of auditors and for all auditing processes
• Internal review of all audit reports before release

Our current quality policy can be provided on request; please contact us under This email address is being protected from spambots. You need JavaScript enabled to view it. for further information.

Our audits are performed in accordance with written procedures. blue inspection has defined a set of standard operating procedures that clearly define the complete audit process. These SOPs are continually updated and improved to ensure that current good manufacturing practices are met. Specifically, there are five SOPs covering the process of auditing:
• SOP H01 (Audit Preparation)
• SOP H02 (Audit Procedures)
• SOP H03 (Generation of Audit Reports)
• SOP H04 (Assessment of Audit Reports)
• SOP H05 (Assessment and Classification of Deficiencies and Non-conformities)

Further details can be found in our audit policy, which will be provided upon request; please contact us under This email address is being protected from spambots. You need JavaScript enabled to view it. for further information.

Auditors

Only highly qualified auditors are authorized to conduct audits for blue inspection. To ensure that audit objectives are met, all auditors are qualified according to written procedures in the framework of our quality management system. Qualification of auditors includes initial training and regular GMP trainings (at least once per year). In addition, our auditors are required to adhere to our established rules (auditor guidance) in relation to:
• Integrity
• Objectivity
• Competence
• Confidentiality
• Impartiality

All possible conflicts of interest are identified and assessed to ensure the independence and impartiality of auditors. The auditors’ decisions are based on objective evidence; they are not influenced by any commercial, financial or other interests.

This email address is being protected from spambots. You need JavaScript enabled to view it.
Phone: +49 251 284 972 93
This email address is being protected from spambots. You need JavaScript enabled to view it.
+49 251 284 972 93
blue inspection

About

Services

Legal

© blue inspection GmbH. All rights reserved.