Quality and compliance

Tereos Starch & Sweeteners’s primary objectives are to ensure the quality and safety of its products while meeting regulatory requirements. All manufacturing units have a third-party certified Quality Management System according to EN ISO 9001:2008 (Quality Management System) and FSSC 22000:2010 (Food Safety Management System), including a HACCP risk assessment analysis.

For the production of its pharmaceutical excipients, Tereos Starch & Sweeteners implemented an integrated quality management system closely following the IPEC-PQG Good Manufacturing Practices guidelines for pharmaceutical excipients whereas Active Pharmaceutical Ingredients manufacturing occurs under cGMP requirements as defined in the ICH Q7 Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients, being implemented as EU GMP Guide Part II. The production of Glucose Monohydrate in Zaragoza, Spain, as an API, is GMP certified.

 

Key practices of the Quality Management System Complying to Good Manufacturing Practices



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