IPEC Federation Position Paper on Supply Chain Security
Latest fatal incidents with contaminated medicinal syrup during 2022/2023.
The presence of numerous cases that have caused several hundred deaths due to the use of excipients of inappropriate quality in pharmaceutical formulations continues to be a global concern.
Some new cases of contaminated medicinal syrups occurred during 2022 and 2023 resulting in more than 300 deaths in different countries in Africa, Asia and the Pan-Pacific region, see recent Medical Product Alert communications by the WHO.
Initial findings from the WHO indicate the following areas require more focus and in-depth investigation:
- Criminal activity
- Falsification of records (namely CoAs)
- Supply Chain complexity
- Lack of, or insufficient QC testing
- Use of industrial grade material
These findings suggest that the current issues are similar to issues identified in cases prior to 2012.
In general, the blending or falsification of well-known pharmaceutical excipients such as propylene glycol, glycerin, maltitol, sorbitol and polyethylene glycol with industrial products seems to be the underlying principle of all the cases referred to in this Position Paper.
The U.S. FDA recently published a new guidance in May 2023 for immediate implementation by industry: Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol.
It contains a general introduction section, a background section, listing the various previous cases and similarities, a section about applicable regulatory requirements in the United States and a fourth section with recommendations to safeguard the quality and safety of medicines from DEG and EG contamination.
- The tools to ensure security of the excipient supply chain are already available, but the following areas require greater awareness and compliance by all actors involved with the supply chain of pharmaceutical excipients:
- Awareness and robust application of guides, standards and regulatory requirements.
- Starting materials to be purchased from qualified and approved suppliers.
- Purchase of ingredients suitable for use in pharmaceutical products/ pharmaceutical grade excipients, no use of industrial grade chemicals as pharmaceutical excipients.
- Robust incoming goods inspection, quality control testing and product release according to applicable monographs or equivalent validated and appropriate internal method(s).
- Full traceability of the supply chain back to the original excipient manufacturer. Awareness and application of Risk Management principles.
- Training system and records.
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