As third-party auditors we inspect the GMP compliance of excipient and API manufaturers – and much more.
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.
For over a decade blue inspection body GmbH has been the leading provider of third party audits.
- Independent inspection of supplier quality for optimum authority acceptance
- Assignment of specialist auditors with experience in the relevant processes/technologies
- Reduction of work-load for in-house QP´s
- Reduction of audit expenses (absence of in-house QP, travel or translation costs, etc.)
- Organizational improvements (planning, VISA, vaccination, language, cultural barriers, etc.)
- Unbiased assessment against established standard
Audits are an integral part of supplier qualification irrespective of the services or products sourced. Based upon accepted standards and current legal requirements, blue inspection body conducts independent and competent audits – worldwide. This service is offered without limitation to every participant of the supply chain e.g.
- Pharmaceutical companies
- (Contract) Manufacturers
- Manufacturing Authorisation Holders
- Consultants or other interested parties
Manufacturing Authorisation Holders (MAH) are responsible for compliance with the Good Manufacturing Practices (GMP) throughout their process chain. These audits can be conducted by qualified persons or outsourced to qualified third parties.
blue inspection body conducts, inter alia, GMP, GDP, GACP, GCP, GLP, GEP and GAMP audits worldwide. Check out the great variety of our service offerings, high quality standards and custom-tailored service.
In line with our accreditation, we offer customised 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.