The introduction is interesting in how it states what is covered and the intent to expand discussion on topics in other guidelines:
"This guideline presents a holistic framework and process for the assessment and control of leachable impurities to further expand the existing ICH guidelines on impurities, including impurities in new drug substances (ICH Q3A) and new drug products (ICH Q3B), residual solvents (ICH Q3C), and elemental impurities (ICH Q3D), as well as DNA reactive (mutagenic) impurities (ICH M7). The framework of this guideline follows the principles of risk management as described in ICH Q9. While the guideline includes materials characterization and process understanding, its primary purpose is to protect patient safety and product quality through assessment and control of leachables in the drug product. Due to rapid advances in materials engineering, device innovations, new manufacturing paradigms and novel therapeutic modalities, the aim is to provide principles and concepts that are forward looking within the scientific and regulatory landscape."
What is also interesting is the acknowledgement and forward looking view of the Working Group that things are changing rapidly and the principles and concepts provided here can be used as the science and technologies change.
It is available on the ICH Quality webpage - just scroll down to Q3E:
https://www.ich.org/page/quality-guidelines#3-8
#ICH #Q3E #extractables #leachables
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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