The safety of liquid pharmaceutical products has been under the microscope following distressing reports of poisoning incidents earlier in 2023. These cases were linked to the contamination of liquid medicines, such as cough syrups, with highly toxic compounds: Diethylene Glycol (DEG) and Ethylene Glycol (EG).
In response to this global public health risk, the FDA (Food and Drug Administration) recently issued a crucial guidance aimed at manufacturers and suppliers of glycols and pharmaceutical ingredients to raise awareness and enforce stricter quality control.
This guidance underscores a fundamental principle of Good Manufacturing Practice (GMP): the manufacturer is ultimately responsible for the safety of the final drug product.
The Hidden Danger: Diethylene Glycol (DEG) and Ethylene Glycol (EG)
Glycols, such as glycerin and propylene glycol, are common ingredients in liquid medicines, acting as solvents, thickeners, or preservatives. However, the structurally similar compounds DEG and EG are highly poisonous when consumed, even in small amounts.
The recent incidents reported to the FDA involved liquid drug products containing glycerin and other glycols that were contaminated with these deadly substances. The FDA's guidance is a direct effort to prevent the use of contaminated products and safeguard consumers globally.
🧪 Key Steps to Ensure Glycol Safety: FDA Recommendations
The FDA's guidance highlights key steps manufacturers must take to ensure the robust detection of DEG and EG contamination. While this guidance represents the agency's current thinking and is not legally enforceable as a regulation, compliance is crucial for preventing future poisoning and maintaining public trust.
1. Do Not Rely Solely on Supplier Certificates
The FDA explicitly recommends against relying only on a supplier’s Certificate of Analysis (CoA) to confirm the safety of glycol ingredients.
- The Manufacturer’s Responsibility: Every component added to a drug product must be tested by the pharmaceutical manufacturer itself. This means manufacturers must be capable of conducting the required tests to verify the absence of harmful contamination.
2. Implement Rigorous Testing Procedures
The guidance emphasizes the need for sensitive, reliable testing methods.
- Action: Manufacturers must ensure their testing methods are adequate to detect even low levels of DEG and EG in all incoming glycol-based ingredients, including glycerin, propylene glycol, and polyethylene glycol (PEG).
3. Review Historical and International Cases
The FDA guidance provides valuable resources, including historical data and international case studies, detailing past incidents of liquid drug product contamination.
- Value: This information helps manufacturers understand the severity of the risk and the precise steps that must be taken to minimize it.
The Takeaway for Manufacturers
The recent FDA guidance serves as a critical resource, outlining steps to minimize the risk associated with the use of glycols. It reinforces that strict adherence to quality control and a proactive testing approach—where the drug manufacturer takes final responsibility for ingredient purity—is the only way to ensure patient safety.
Pharmaceutical companies must incorporate these recommendations into their Quality Management System (QMS) immediately to prevent recurrence of this serious public health threat.
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