GMP audit for monitoring GMP compliance

The blue inspection body is the first pharmaceutical service provider in the European Union to offer an accredited GMP audit for excipients and active pharmaceutical ingredients of medicinal products (called API audit). Working on behalf of pharmaceutical manufacturers, the auditors of blue conduct audits to ensure that suppliers are producing worldwide in accordance with the rules of good manufacturing practice (GMP) for active pharmaceutical ingredients. With blue such a third party audit obtains maximum impartiality.

GMP-Audit
accredited third-party audit (API audit)
GMP audit of active pharmaceutical ingredients    
internationally usable audit report          
competent, impartial GMP auditor 
tested quality
standardized procedure
cost-effective implementation
 

Those manufacturing and placing pharmaceuticals on the market in the European Union are obliged to provide proof of Good Manufacturing Practice throughout their entire process chain. This includes GMP compliance of bought-in starting materials and active pharmaceutical ingredients by means of a third party audit. blue inspection body GmbH carries out the necessary API inspections on behalf of the pharmaceutical industry worldwide.

Their special feature is that each audit report provided by blue will be recognized internationally by regulatory authorities, since the blue inspection body is accredited according to ISO standard ISO 17020 for the „inspection of excipient and active pharmaceutical ingredient manufacturers for pharmaceutical products and determination of the conformance with international GMP rules“.



 
blue inspection body

Related news
Article: Auditing / Qualification of Active Pharmaceutical Ingredient Manufacturers by Accredited Inspection Bodies >
Article: API Manufacturing: Complying with International GMP Regulations >