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CGA M-25 PDF
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ICH Q3D Risk Assessment Report Elemental Impurities in Medicinal Gases, First Edition
| Published by | Publication Date | Number of Pages |
| CGA | 07/29/2020 | 53 |
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CGA M-25 – ICH Q3D Risk Assessment Report Elemental Impurities in Medicinal Gases, First Edition
ICH Q3D recommends a science and risk-based approach to evaluate the potential for introduction of EIs into the drug product and to determine if additional controls need to be included in the overall control strategy to ensure product quality and safety. The overall process follows the sequence identify, evaluate and summarise.
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