090317 pm auditberichte-en-f
Accredited GMP audit reports for additional
active pharmaceutical ingredients
Münster, 23 March 2009.
During March 2009, pharma service provider
Diapharm (www.diapharm.com) has commissioned audits of GMP
compliance in the production of the active pharmaceutical ingredients
Caffeine, Theophylline, Phenazone, Metamizole-Sodium and Trimethoprim
by manufacturers in the Shandong region of China. Diapharm will make the
resulting accredited GMP audit reports available to European medicinal
product manufacturers under a cost-sharing arrangement.
Regular on-site audits of good manufacturing practice (GMP) at the active
pharmaceutical ingredient manufacturer’s premises are an important means
of improving medicinal product safety. They are required before active
pharmaceutical ingredients can be imported into Europe and used to make
Press office Hafenweg 18-20 D-48155 Münster
finished medicinal products. “Our programme of accredited audit reports
supplied on a cost-sharing basis enables marketing authorisation holders to
monitor active pharmaceutical ingredient manufacture at a high quality level
Tel.: +49 (0)251 - 60935-17 email@example.com www.diapharm.com
– but at a fraction of the cost”, explains Dorothee Klöpf, one of those
responsible for the Diapharm audit service.
co-operate Wegener & Rieke GmbH
Local audits of active pharmaceutical ingredient manufacture are carried out
for Diapharm by the accredited inspection body blue inspection body GmbH.
Apart from the Swiss health agency Swissmedic, blue is at present the only
GMP auditor in Europe to have ISO/IEC 17020 accreditation.
You can download press releases of Diapharm and photos in print quality:
In addition to the newly added active pharmaceutical ingredients Caffeine,
Theophylline, Phenazone, Metamizole-Sodium and Trimethoprim
already provides accredited audit reports for active pharmaceutical
ingredients from a range of manufacturers, such as Atorvastatin,
Cefpodoxime proxetil, Cefuroxime axetil, Cimetidine, Ciprofloxacin,
Clarithromycin, Dextropropoxyphene HCl, Doxycycline, Finasteride,
Levofloxacin, Mirtazapine, Molsidomine, Ofloxacin, Pioglitazone, Piracetam,
Ranitidine HCl, Repaglinide, Sertraline, Sotalol, Sumatriptan and
Further information and the full list of audited manufacturers and active
pharmaceutical ingredients are available from Karin Müller, Diapharm
GmbH, phone: +49 (0)251 60935-11, e-mail: firstname.lastname@example.org.
Background information: Diapharm
Diapharm supports companies in the medicinal and health products industry
in all regulatory, medical and pharmaceutical matters to do with medicinal
products, medical devices, food supplements, biocides and cosmetics. A
team of approximately 90 employees in Münster, Bielefeld, Oldenburg and
Lübeck (Germany) provides, inter alia, strategic advice, management and
responsible care for trademarks and product portfolios. Diapharm is present
throughout Europe with partners in France, Great Britain, Poland, Portugal,
Slovenia, Spain, the Czech Republic and Hungary.
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