The abbreviation “GxP“ combines guidelines for “good working practices“ pertaining to various branches of the pharmaceutical industry…
Derived from the normative standards and based on the corresponding experience with quality management systems (QM systems) in the area of ISO standards 9001, 13485 and 15378, blue offers pure QM system audits…
Certain projects require custom-tailored audits or even expert opinions…
blue is an EXCiPACT registered certification body. The EXCiPACT certification scheme is an initiative of industrial associations from excipient and pharma suppliers, aiming for a professional surveillance of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) compliance for Excipients. The independent Third-Party-Audits of blue, which are conducted according to predefined standards, have therefore been especially qualified in addition by EXCiPACT.
In line with our accreditation, we offer customized third-party audits for all areas of pharmaceutical industry.
Our services encompass product-specific compliance audits as well as reviews of system conformity and customised expert opinions, such as:
Pharmaceutical companies face ever-changing market forces and statutory regulations. Hence, they must demonstrate increasingly systematical risk management and consistent GMP compliance. We offer support and guidance in pharmaceutical quality management.
Blue Inspection Body conducts, inter alia, GMP , GxP and mock audits worldwide. Check out the great variety of our service offerings, high quality standards and custom-tailored service.