Zentralinstitut medicament research GmbH: Control laboratory receives manufacture permission for the release
Manufacture permission for the load release receive: Dr. Sven of olive Kruse is expert person Zentralinstitut medicament research GmbH.
(openPR) - Münster, 21 February 2007 - which Zentralinstitut medicament research (ZA) GmbH, the order laboratory of the DiapharmGruppe (www.diapharmgruppe.de), has as one of the first independent Prüflaboratorien in Germany its own manufacture permission for the load release in accordance with § 13 medicament law received. Adept persons, who release medicaments for the market, can fall back in the future to certified Testate of the ZA GmbH. At the same time with the distribution of manufacture permission the responsible supervising authority renewed also the GMP certificate (Good Manufacturing Practice) the ZA GmbH.
“Received now a completely new priority for our customers”, ZA-managing director Dr. Sven of olive Kruse, which takes the responsibility for certifying of results of analysis with the ZA GmbH as an expert person, stresses our release-relevant analyses. With the 14. AMG novella had been defined the release of medicaments as part of the production. Since that time a designated expert person of the pharmaceutical entrepreneur must supervise the entire production process and guarantee the quality of the medicament. In the new medicament and active substance manufacture regulation as well as in appendix 16 of the GMP manual that she can rely thereby also on certificates of experts persons, those is fixed for subranges, as, has responsibility the release analysis.
The ZA GmbH takes over all tasks of laboratory for medicaments, Kosmetika, food auxiliary means or medicine products on behalf from wage manufacturers and pharmaceutical enterprises. The spectrum reaches from the analytic consultation over the development and validating of methods up to stability tests. Zentralinstitut medicament research was created before ten years of the Federal association of the medicament manufacturers (BAH). Since 2002 the enterprise belongs proportionately, since 2005 completely to the DiapharmGruppe.
(approx. 1,880 indications)
Contact:
DiapharmGruppe
Pressestelle
Lingener STR. 12
D-48155 Münster
Ansprechpartnerin:
Nicole Sibbing
Tel.: +49 (0) 251 - 60935-17
nicole.sibbing@diapharmgruppe.de
www.diapharmgruppe.de
Agency contact:
CO-operate Wegener & Rieke GmbH
Zumsandestrasse 32
D-48145 Münster
Partner:
Christian Rieke
Tel.: +49 (0) 251 - 3222611
wort@co-operate.net
www.co-operate.net
Background information: DiapharmGruppe
For the optimal management of the Produktportfolios of medicaments and health products the DiapharmGruppe offers comprehensive and individual service and consulting services for enterprises within the health central range. The DiapharmGruppe with its team of approximately 60 qualified coworkers takes over when desired the strategic consultation, the management or the responsible person care of complete Produktportfolios. She gains a conversion of 10 millions euro. Societies of the DiapharmGruppe are Dr. Stefan Sandner GmbH (Pharmaceutical management & Portfolio Solutions), Dr. Kolkmann & Partner GmbH (Drug Registration & new Projects), Dr. Middeler et al. GmbH (Biotechnology & Medical DEVICE), Zentralinstitut medicament research GmbH (Analytics), Dr. Ebeling & Assoc. GmbH (Medical Affairs & Pharmacovigilance), Beate Beime & team (Clinical Research Coordination) as well as the HÄLSA Pharma GmbH (Responsible Manufacturer & Product release).
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