Lieferantenqualifizierung unter Aspekten der Qualitätssicherung in einem internationalen Pharmaunternehmen
Dr. Michael Pfeiffer und Dr. Harald Scheidecker
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein
Qualification of Suppliers with Regard to Quality Assurance Aspects in an International Pharmaceutical Company
The following publication describes a prospective procedure to (re-)qualify suppliers of ingredients, packaging materials, medical devices, contract manufacturers/laboratories and service providers. A structured risk based assessment is used to decide the necessity of on-site audits. A network approach of already available in-house supplier-/product relevant information is managed by a so called “Quality Radar” (Q-Radar). By this risk assessment the point of time for an on-site audit is ascertained. Boehringer Ingelheim Pharma GmbH & Co. KG, Pharma manufacture division, could reduce the number of on-site audits within the past two years by using the Q-Radar model by more than 30 %. All normative requirements were fulfilled and the quality supervision of suppliers was intensified.
pharmind 2010, Nr. 3, Seite 540