Extractable and leachable studies of single- and multi-use manufacturing components should be followed up with a chemical safety assessment to understand the chemical risks based on the toxicity of the chemical, the dose and the exposure duration of the drug product, and the patient population for its intended use. This case study will illustrate considerations when conducting a chemical safety assessment, the pitfalls of having unknown chemicals in your chemistry reports, options for mitigating potential risks, and the importance of using toxicologists skilled in these assessments.
Key Lessons Learned:
- Not all chemicals are equal when it comes to safety risks.
- Unknown chemicals can cause unnecessary challenges in the safety assessment.
- Safety assessments should be conducted by qualified professionals.
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