For products that come into direct contact with the human body, for example by ingestion or skin exposure, producers as well as regulators and authorities place a high standard of care to ensure product quality and safe handling. Safe handling considerations assure minimized risk of contamination and complete traceability from production to delivery. The member companies of the Propylene Oxide and Glycols Sector Group act according to the principles of Good Manufacturing Practices as laid down in the Cefic „Guidelines for Handling and Distribution of Propylene Glycol USP/EP".
Pharmaceutical propylene glycol is monitored, controlled and tracked during production, filling, storage, transport and delivery. The requirements in regulatory and industry standards include specifications 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 dedicated transport containers for shipment of pharmaceutical propylene glycol; if not dedicated, containers must undergo a specific cleaning and inspection procedure before transporting pharmaceutical propylene glycol.
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.