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.
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.