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

Confidentiality – permanent

blue inspection body GmbH ensures enduring confidentiality of documents and data. As an accredited inspection body we continue to keep such information secret in the interests of our clients and the companies inspected by us even after completion of an GMP audit.

Accreditations

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

EXCiPACT audits

blue inspection body is an EXCiPACT registered certification body for excipients and active ingredients.

Non-disclosure rules for third party audits

During their inspections GMP auditors gain deep insights into the production processes of manufacturers of active pharmaceutical ingredients. They must also be familiar with the processing of the active pharmaceutical ingredients by the manufacturer of medicinal products to be able to conduct a targeted GMP inspection. Blue inspection body GmbH ensures confidentiality in respect of all documents and other information that we receive in conjunction with GMP audit mandates. Every audit report of blue has to be factually accurate, impartial and fair. Unless there is an obligation to provide information to the authorities documents and information are only divulged with the prior approval of the client or a duly authorized party.

Strict standards apply to the confidential handling of documents received by a GMP auditor of blue inspection body GmbH from clients during the course of an third party audit. According to the accreditation requirements of ISO 17020 such documents have to be treated confidentially and all records of a GMP audit have to be permanently kept under lock and key to prevent any unauthorized access. We use a multi-stage system to guarantee that these requirements are fulfilled. All our employees are regularly trained in the handling of confidential documents and data. The accreditation body responsible for the supervision of blue inspection body GmbH, Deutsche Akkreditierungsstelle (DAkkS), regularly monitors our adherence to the principle of secrecy.

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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