Privatsphäre-Einstellungen

Risikomanagement bezüglich der Ausgangsstoffe

Karl Metzger

Welding GmbH & Co. KG, Hamburg

Korrespondenz: Karl Metzger, Welding GmbH & Co. KG, Esplanade 39, 20354 Hamburg (Germany), e-mail: karl.metzger@web.de

Risk Management with Regard to Starting Materials

The topic Starting Materials should be integrated part of the risk management. The guideline ICH Q9 raises − mainly in Annex 2 − questions regarding the assessment of the material management. For risk identification regarding starting materials mainly the manufacturing process, the supply chain and the internal management of starting materials have to be assessed.
Risk management as part of the materials management according to ICH Q9 should cover the following topics:

• Assessment and evaluation of suppliers and contract manufacturers
• Starting material
• Use of materials
• Storage, logistics and distribution conditions

Key words Ausgangsstoff • HACCP • Lieferantenqualifizierung • Risikomanagement • Transport