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Home » Propylene glycol USP/EP » Quality of care

Quality of care

Seamless quality and hygiene monitoring through to delivery

For products that come into direct contact with the human body, for example by putting them on the skin or ingesting them, producers as well as regulators and authorities place utmost care on ensuring strict hygiene and providing high purity. The member companies of the Propylene Oxide and Glycols Sector Group work according to the principles of Good Manufacturing Practices as laid down in the Cefic „Guidelines for Handling and Distribution of Propylene Glycol USP/EP“.

Any material or container that comes into contact with pharmaceutical propylene glycol during production, filling, transport and delivery is seamlessly monitored, controlled and tracked. The rules laid down in the official documents include instructions on equipment, storage, sample taking, personnel health and qualification, design and construction details, sealing and cleaning instructions, loading, transporting and unloading instructions, packaging and quality analysis. For example, it is highly recommended to use a lorry solely for transport of pharmaceutical propylene glycol; if ever used for something else it must undergo a specific cleaning and inspection procedure before transporting propylene glycol again.

Industry initiative: Safety and Quality Assessment System

In order to ensure best practice and the highest quality and safety standards throughout the entire value chain, the European Chemical Industry Council (Cefic) and the European Federation of Chemical Distributors (FECC) have initiated a uniform assessment system to apply to the whole value chain (ESADII): Under the highly comprehensive Safety and Quality Assessment System (SQAS) scheme, independent auditors regularly assess authorised partners on the basis of a commonly-agreed set of quality controls, which at present contain more than 800 questions. Based on the quality assessment reports, which can be made public, the manufacturers of propylene glycol can manage the quality and performance control of their distributors.