GMP audits

GMP auditing of manufacturers of active substances is a precondition for approval and batch release of medicinal products. We offer the required high-quality GMP compliance audits. blue inspection body monitors Good Manufacturing Practice of manufacturers of active substances, excipients and finished medicinal products, as well as of manufacturers of primary and secondary packaging materials worldwide.

Accreditations

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

Excipient audits

With the same diligence as for APIs, blue inspection body also audits excipients.

GMP for excipients

On behalf of our clients we examine whether excipients meet GMP requirements.

Repeated on-site audits are mandatory for ensuring GMP and GDP compliance of APIs and excipients. This has been unequivocally clarified in legal regulations such as directive 2011/62/EU. Having successfully completed more than 1.000 audits, blue inspection body is your partner of choice.

We audit

  • Small, medium and large manufacturer
  • APIs from basic chemicals and excipients to highly sophisticated manufacturing processes
  • Plant material cultivation and extraction, chemical synthesis, fermentation, animal and cell culture derived products
  • Suppliers globally
  • Standard compliance according to ICH Q7, IPEC excipients, among others

Our third-party audit service is based on an implemented quality system, i.e. our auditors are qualified with an academic degree in natural science, years of professional working experience in the pharmaceutical industry and considerable audit expertise. Our audits are prepared, conducted and post-processed based on a risk-based approach. This ensures a standardised, high quality procedure with trustful and sustainable audit results that are accepted by regulatory authorities around the globe.

Contact

blue inspection body GmbH
Hafenweg 18-20
48155 Muenster, Germany
Phone: +49 251 9759950-100

contact(at)blue-inspectionREMOVETHIS.com
china(at)blue-inspectionREMOVETHIS.com
india(at)blue-inspectionREMOVETHIS.com