Diapharm to conduct bundled GMP audits for DSM

DSM Nutritional Products and DSM Pharmaceutical Chemicals have mandated Diapharm GmbH to carry out bundled audits on the production of numerous vitamins, medical pharmaceuticals and fatty acids in compliance with the European Guide to Good Manufacturing Practice (GMP). The arrangement will allow the company to more efficiently structure the regularly required GMP audits. In the coming weeks, pharmaceutical service provider Diapharm will organise monitoring of the manufacturing processes of DSM production sites in Grenzach (Germany) and Dalry (UK). The auditing process began at DSM Pharmaceutical Chemicals in Linz (Austria) on September 4th and 5th, 2012.

Bundling audits allows greater inspection depth

Pharmaceutical companies are obliged to regularly audit the GMP of their suppliers. Often, auditors travel round the globe to audit just one active substance: “Our goal is to bundle GMP audits and thereby increase inspection depth”, said Stephan Heck, Director of DSM Nutritional Products AG. “With Diapharm we’ve found a partner that not only fulfils the legal requirements but goes beyond these to also fulfil our Swiss quality expectations”. In 2011 Diapharm audited production of numerous vitamins and carotenes at DSM locations in Sisseln (Switzerland) and Village-Neuf (France).

DSM customers can obtain monitoring reports from Diapharm

This year, inspection of production for the pharmaceutical industry of vitamins B1, B2, B5, B6, C, D3, active pharmaceutical ingredients and of polyunsaturated fats, among others, will be done at Grenzach, Dalry and Linz. Now, instead of conducting their own audits, DSM customers can obtain the officially approved monitoring reports from Diapharm. The pharmaceutical service provider bundles the individual monitoring requirements of pharmaceutical companies and co-ordinates the respective GMP audits. The on-site audits are carried out by the independent, officially accredited inspection agency, blue inspection body GmbH.

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