Pharma service provider Diapharm is now offering accredited shared third-party audits for active pharmaceutical ingredients (APIs). In a shared audit several medicinal product manufacturers jointly commission the check of production conditions for a starting material or API such as ibuprofen or naproxen. The resulting audit report serves to prove whether the rules of good manufacturing practice (GMP) are followed in the manufacture of the ingredient. This proof of GMP compliance is mandatory for European manufacturers of medicinal products. “Accredited third-party audits offer additional security, since they are also recognized internationally by the authorities”, explains Dorothee Klöpf of Diapharm, responsible for the GMP audit service. For these checks Diapharm collaborates with the independent, accredited blue inspection body GmbH. Upon request, blue also undertakes the management of deficiencies.
About 80 percent of the starting materials and APIs used in the production process of medicinal products in Europe come from third countries such as India or China. With the shared audit concept, Diapharm spreads the cost of auditing the APIs among several parties, interested medicinal product manufacturers in Europe who jointly commission an audit of an API manufacturer.
For the 4th quarter of 2008 Diapharm (diapharm.com) is coordinating shared-audit trips to China and India. Audits are to be made of, among others, manufacturers of acetylsalicylic acid, atorvastatin, ciprofloxacin, caffeine, donepezil, hydrocortisone, ibuprofen, levofloxacin, lovastatin, metamizole, naproxen, naratriptan, paracetamol, pravastatin, propyphenazone, rizatriptan, rosiglitazone, rosuvastatin, simvastatin, sotalol, sumatriptan, theophylline, trimethoprim and zolmitriptan. Diapharm also supplies ready-made GMP audit reports for a steadily increasing number of starting materials and APIs.