Diapharm organizes GMP inspection at Ranbaxy

During May and June, German pharmaceutical service provider Diapharm will perform an audit regarding Good Manufacturing Practice-compliance  in the production of seven active pharmaceutical ingredients at the  domestic plants of leading Indian drugmaker Ranbaxy Laboratories.  Diapharm will make the resulting accredited audit reports available to  medicinal product manufacturers under a cost-sharing arrangement.  Production of the active ingredients cefaclor, cefpodoxime, cefuroxime,  clarithromycin, ofloxacin, ranitidine and sertraline is to be audited.

In recent months, Ranbaxy fell victim to conflicting decisions by the  supervisory authorities: after a GMP audit in September 2008 the US Food  and Drug Administration accused the company of defects in the production  process and imposed import bans (Marketletters passim). By contrast,  after a joint audit in October 2008 the Medicines and Healthcare  products Regulatory Agency (MHRA) in the UK and the Therapeutic Goods  Administration in Australia renewed Ranbaxy's GMP certificates - for  three in Europe and two years in Australia, the German firm noted.

"These differing decisions by the authorities confused medicinal product  manufacturers worldwide," commented Dorothee Klopf of Diapharm's audit  service. Manufacturers are obliged to ensure that the active ingredients  they purchase for their medicinal products are of impeccable quality.  Diapharm is now bundling enquiries for current audit reports. "This  cost-sharing arrangement allows marketing authorization holders to  monitor production of their active ingredients at the highest level -  but at a fraction of the cost of an individual audit," Ms Klopf  added.