Certified API audits: Hälsa Inspection Body obtains first accreditation in Europe

Lübeck, Münster (Germany), 31 October 2007. As the first audit service provider in the European Union the Hälsa Pharma GmbH Inspection Body (www.blue-inspection.com) has obtained an accreditation for the "Inspection of API manufacturers and manufacturers of starting materials for pharmaceutical products and for certification of conformity with international GMP rules". From now on pharmaceutical manufacturers can rely on the service of Hälsa auditors in order to ensure that the starting materials processed by them comply with the rules of Good Manufacturing Practice (GMP). The accreditation is an important quality criterion for the ordering customer as it ensures that all Hälsa audits are performed effectively, with a high level of competence and on a fully independent basis. The resulting audit reports are internationally accepted due to the worldwide harmonised accreditation standards ISO/IEC 17020.

In addition to that, audit pools can be created in cooperation with the DiapharmGruppe: Different companies which use the same API supplier can jointly commission an accredited API audit via the DiapharmGruppe. This approach allows pooling of the investment in the audit and therefore causes a distinct reduction of costs for the individual pharmaceutical manufacturer or contract manufacturer. The Hälsa Pharma Inspection Body performs such audits worldwide.

According to the European Directive 2001/83/EC manufacturers of medicinal products in Germany must warrant that all active substances processed by them are manufactured according to GMP rules. This new obligation is controlled by the supervisory authorities during their routine GMP inspections with increasing strictness. It is estimated that almost 80 per cent of all active substances processed in the EU and in the USA come from third countries such as India or China. In many cases service providers who have specialised in contract auditing perform the necessary audits on-site by order of the pharmaceutical manufacturers. Companies who decide not to use the advantages of third party audits will have to travel a lot in the future in order to assure GMP compliance for every active ingredient on-site, follow-up audits in intervals of two to three years included.

However, there are some special prerequisites to be fulfilled for such third party audits, as stipulated by competent authorities. For example, the pharmaceutical manufacturer himself has to qualify the auditor in order to assure competence and independence of his service provider. In case of an accredited auditor this basic qualification is performed by an authorised body – in case of the Hälsa Pharma GmbH Inspection Body by the German DAP Accreditation System for Testing (Deutsches Akkreditierungssystem Prüfwesen GmbH)

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Contact:
Hälsa Pharma GmbH
Lingener Str. 12
D-48155 Münster

Contact person:
Ralf Sibbing

Tel.: +49 (0)251 - 60935-15
ralf.sibbing@diapharmgruppe.de
www.diapharmgruppe.de


Agency contact:
co-operate Wegener & Rieke GmbH
Zumsandestraße 32
D-48145 Münster

Contact person:
Christian Rieke

Tel.: +49 (0)251 - 3222611
wort@co-operate.net
www.co-operate.net

Hälsa Pharma GmbH is a contract auditor for the pharmaceutical industry. Hälsa audits manufacturers of active pharmaceutical ingredients that are being used in medicinal products. As the first API auditor in the European Union, Hälsa has been accredited as an Inspection Body (DAP-IS-4216.00).

This release was published on openPR.