“blue inspection body GmbH” and “INSPECT2gether” collaborate to achieve common goals to enable and perform Shared Audits. To combine strength of experience with a proven track-record of quality expectations from “blue inspection body” versus the flexible and cost effective Shared Auditing platform from “INSPECT2gether”. This partnership will strongly support the Pharmaceutical Industry in Audit performance based on competency.
Who is blue inspection body GmbH
"blue inspection body GmbH", is Europe's only private operating audit company, which has ever been accredited according to the ISO/IEC 17020 type A, the highest standard of independence, impartiality and quality possible.
"blue inspection body" created a symbiosis of the GMP requirements (content) with an accredited system of the DIN ISO world (normative). Through the active involvement of state-recognized GMP inspectors of the state authorities in the accreditation process of a “type A inspection body”, the more content-oriented GMP principles are linked to the more normative DIN EN ISO rules.
Since 2008 "blue inspection body" are performing high quality GxP and excipient audits worldwide. As the leading inspection body for accredited GMP audits, they have performed by far more than 1,000 audits worldwide and have verified compliance with the "good manufacturing practice". In addition to the standardized processes and requirements for accredited audits, they also offer to conduct audits that have been designed to meet your individual needs entirely, e.g. FDA readiness, GDP, packaging and others. As a full-service audit inspection body, they can also take care of the entire audit process, from planning, execution, reporting and tracking possible CAPA measures of an audit.
All the auditors have a scientific background with many years of professional experience in the pharmaceutical industry including extensive audit experience. Most of them are QP´s as well. In order to maintain the high quality standards at all times, all auditors are trained on an annual basis and accompanied during the course of the accreditation by the German accreditation authority body “DAkkS” (www.dakks.de) during audits.
If you are looking for a reliable solution to reduce the audit burden as either a manufacturer having the responsibility to perform supplier audits, or as supplier having the same audit performed for a mutual number of manufacturers for the same API for instance, we recommend Shared Auditing performance.
Shared Auditing will directly reduce your internal audit related costs as well as providing the advantage to get a high-quality audit report that is internationally accepted for a minimum of costs.