The pharma services provider will inspect facilities producing APIs or starting ingredients on behalf of multiple companies that use the ingredient.
From the inspection Diapharm produces an audit report establishing if the facility is compliant with good manufacturing practices (GMP).
By jointly inspecting facilities manufacturers share the financial burden imposed when ensuring the quality of materials they purchase. Diapharm believes this provides a cheaper way for manufacturers to gain accreditation with regulatory bodies.
The company attempts to generate additional savings for its clients by inspecting multiple facilities in a region in a single trip.
By performing ‘audit tours’ of Europe, China, India, and the US, Diapharm says it generates savings in travel and translation costs, which are passed on to its clients.
Dorothee Klöpf, of Diapharm’s GMP audit service, said: “Accredited third-party audits offer additional security, since they are also recognised internationally by the authorities.”
In the fourth quarter of 2008 Diapharm will be inspecting facilities in China and India producing a wide range of ingredients, including atorvastatin, simvastatin and donepezil.
Manufacturers sourcing ingredients from facilities that Diapharm has up-to-date GMP audits for can simply purchase the report, saving on the cost of additional inspections. A list of available reports can be found here.
The audits are performed in collaboration with blue inspection body, which recently achieved a type ‘A’ independence rating under the German accreditation system.
Gaining this accreditation demonstrates blue’s independence and that conflicts of interest do not impact on the integrity of its inspectors. blue also undertakes the management of deficiencies for Diapharm on request.
Increased 3rd party inspections
Third-party inspections of APIs and excipients have become an increasingly prominent topic in recent months, with both the European Commission (EC) and the US Food and Drug Administration (FDA) looking into it.
It is viewed as a way to prevent counterfeit products reaching the marketplace by the EC and the FDA is also considering it as part of its "Beyond Our Borders" initiative.
Diapharm is among the companies poised to capitalise should the regulatory bodies decide to implement the proposals.