Why a Third-Party Audit for APIs?

Sourcing of starting materials and active pharmaceutical ingredients from third countries is common practice, particularly in the production of generics. The main supplier countries are China and India.

Certificates of suitability (CEP), ISO or GMP certificates from these third countries are not sufficient proof of the compliance with GMP Guidelines for the production of a pharmaceutical product. Only an API audit for a specific active pharmaceutical ingredient which is performed on site is accepted by the regulatory authorities as proof of the GMP compliance of the API manufacturer. Such an GMP audit must be performed regularly, every two to three years. A GMP audit in the form of a third party audit by contract partners is explicitly permitted.

Accredited Safety …

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 this is done centrally by a notified body, the “Deutsche Akkreditierungssystem Prüfwesen” (DAP). The quality of the content and the depth of the inspections are also checked by the DAP. 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.

… for Drug Manufacturers

The Blue Inspection Body GmbH performs a 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.

… for API Manufacturers

We can act directly on behalf of the manufacturers of APIs: Blue undertakes all aspects of GMP compliance monitoring and performs a third party audit on the initiative of the manufacturer. The manufacturer can then make reports on the audited active pharmaceutical ingredients available to his customers. Unlike GMP certificates from a particular country – which according to the GMP guideline are explicitly not recognized as GMP audit in the EU – thanks to accreditation, certified active pharmaceutical ingredient inspections by Blue may be used internationally.

… for Suppliers

Suppliers of pharmaceutical excipients and active pharmaceutical ingredients also make use of the service of Blue Inspection BodyGmbH. Based upon the recognized audit reports of the accredited inspection body, an independent qualification and surveillance of the API manufacturers is achieved. Simultaneously these accredited audit reports represent a valuable extension of the necessary regulatory GMP documentation for drug manufacturers.