Di Ethylene Glycol (DEG), an odorless and colorless organic chemical compound, is used for industrial applications, mostly as a solvent in pharmaceuticals, textiles, and plastic manufacturing, while a key ingredient in the production of antifreeze, resins, and plastics.
Recently, the contamination of drug components has been exposed with di ethylene glycol (DEG) and ethylene glycol (EG). That’s why the FDA has issued a testing guidance, especially in the case of high-risk drug products, for urgent implementation. This guidance replaces the previous guidance of the FDA of 2007, which is highly considerate for pharmaceutical manufacturers and suppliers to avoid the risks of contamination with high-risk drug products during testing DEG.
In today’s blog, we will discuss the testing guidance issued by the FDA outlining regulatory and statutory provisions complying with manufacturing practices to prevent further poisoning accidents. Let’s begin.
FDA Guidance on Di Ethylene Glycol Testing for High-risk Drugs
Truth be told, DEG and EG contamination and poisoning outbreaks in terms of some high-risk drug products are not something new. There have been numerous cases worldwide, leading to the deaths of hundreds. Considering the past and recent contamination incidents, especially for di ethylene glycol (DEG), the FDA has issued this guidance outlining the statutory and regulatory provisions.
First, understand the significance of this guidance on DEG testing for high-risk drug components.
The core reason behind issuing this guidance is the lapses in the supply chain of DEG and the lack of required testing of high-risk drug products contaminated by DEG. On the other hand, high-risk drug component distribution chains are not apparent from certificates of analysis (COAs), which liquid drug product (oral) manufacturers rely on. As a result, DEG-contaminated products get into the pharmaceutical supply chain of raw materials and end up in final drug components. That’s why an immediate implementation of this guidance is issued to identify DEG contamination incidents and mention CGMP requirements to control and prevent further similar events from occurring.
Here are some current good manufacturing practices (CGMP) are highlighted in the guidance:
- Every manufacturer and supplier must do identity testing of each drug product, especially the specific ones if they exist.
- It’s crucial to perform these tests on samples of each lot of drug components for every shipment before distributing them in the market for use.
- Manufacturers should partner with a quality unit to approve or reject the drug components and raw materials used in the production. On the other hand, the unit carries out the process by following written procedures so components that don’t meet the specifications mentioned there can be rejected.
- All the shipment of drug components should comply with identity standards, while not accepted without or lacking a DEG or EG test.
Now, this guidance primarily addresses pharmaceutical manufacturers, suppliers, and repackers of high-risk drug products, especially those that are at high risk of contaminating with DEG and EG, such as propylene glycol, hydrogenated starch hydrolysate, sorbitol solution, glycerin, maltitol solution, etc.
Other regulatory requirements and additional recommendations
Besides these CGMP requirements mentioned above, a few more recommendations, including regulatory requirements, are added to the guidance for DEG and EG testing to control further contamination.
- Specific identity analysis on samples of high-risk drug components of each lot and limit test for DEG using it before manufacturing a drug product
- Include a suitable procedure to quantify and identify DEG and EG to ensure its safety limit of 0.10% NMT (equivalent to the USP-NF monograph identification test).
- Have knowledge of the latest high-risk drug component supply chains.
- Submitting post-market safety and quality reports of drug products is a requirement for the manufacturers and suppliers holding New Drug Applications and Abbreviated New Drug Applications, while a Field Alert Report (FAR) should also be submitted to the FDA if the test outlines that the DEG or EG levels in the drug component are more than the safety limits.
In Conclusion
Besides this guidance, the FDA recommends taking precautions during testing and lot acceptability to ensure no risks of DEG or EG contamination. And, when it comes to a reliable DEG manufacturer, distributor, and supplier, count on us. At Chemical Iran, we offer the best quality and purest di ethylene glycol (DEG) adhering to this guidance. Get a quote now for a bulk order!
