Starting materials used in the manufacture of pharmaceutical products often change hands many times before reaching the end user. Along the distribution, packaging and trade chain there are many opportunities for the starting material to be altered or become unsafe. Propylene glycol of pharmaceutical quality is a high purity product having various applications. Contamination or mislabelling could have serious consequences on the quality of the product and the health of the end user. Intermediate handling should therefore be subject to strict conditions.
The European Chemical Industry Council (CEFIC) has developed safe handling guidelines based on good manufacturing practices. Six major European producers of monopropylene glycol USP/EP (pharmaceutical grade) have jointly committed to enforce compliance with these guidelines in their own facilities and in downstream distribution chains by intensive auditing. CEFIC recommends that these guidelines be adopted as a code of practice by all parties involved in the distribution of propylene glycol (pharmaceutical grade). End users should also consider these guidelines for their own handling and storage purposes and impose them on their own contractors. All suppliers should operate in compliance with this code of practice with full traceability and transparency as to the origin of materials through a certificate of origin.
The guidelines are available in English, French, German, Spanish and Italian and are posted on the CEFIC website at http://www.cefig.org.
Guidelines for Handling and Distribution of Propylene Glycol USP/EP. Available from the Propylene Oxide/Propylene Glycols Sector Group of CEFIC, European Chemical Industry Council (CEFIC), Brussels, Belgium.