GMP audit - monitoring API cGMP 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)
cGMP audit of active pharmaceutical ingredients
internationally usable audit report
competent, impartial GMP auditor

standardized procedure
cost-effective implementation

Copanies manufacturing and placing pharmaceuticals on the market in the European Union must provide proof of GMP throughout their process chain. This includes compliance with cGMP rules for starting materials and active pharmaceutical ingredients by means of a third party audit. blue inspection body carries out the necessary API inspections on behalf of the pharmaceutical industry worldwide.

Download
the accreditation document

The special feature of blue audits is that each audit report provided will be recognized internationally by regulatory authorities, since 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“.