Sourcing of starting materials and active pharmaceutical ingredients from third countries is common practice, the main supplier countries being China and India. However, CEPs, ISO or GMP certificates from third countries are not considered sufficient to ensure compliance with GMP Guidelines. Only API audits of the specific active pharmaceutical ingredients, performed on site, are accepted by the regulatory authorities. Third party audits by contract partners are explicitly permitted.

Authorities make third party audits subject to a number of conditions: the drug manufacturer must for example ensure that auditors have the requisite professional expertise and independence. At the Blue Inspection Body GmbH this is done centrally by a notified body, the Deutsche Akkreditierungsstelle (DAkkS). The quality of the content and the depth of the inspections are also checked by the DAkkS. Accreditation as an inspection body is thus an important quality criterion for those commissioning third party audits. It ensures that a GMP inspection is impartial and is performed to a high standard of quality, reliability and efficiency.

Blue Inspection Body GmbH performs GMP audits for drug manufacturers and contract manufacturers on the basis of Part II of the EU GMP guideline. The first step is to establish what specific requirements the client wants his active pharmaceutical ingredient to meet.

The GMP auditor prepares a third party audit plan on this basis and suitable auditors are assigned. The actual inspection is performed on site at the premises of the API supplier in accordance with specified standards. In an internal review process, an assessment is made of the quality of the inspection itself, the GMP compliance found and the measures proposed by the supplier to eliminate any deficiencies identified. The client receives a full, certified audit report for final assessment.