Q&A covering the key components, risk assessment principles, study design expectations and control strategies outlined in the latest draft guidance
The draft ICH Q3E guideline introduces a globally harmonised, risk-based framework for managing extractables and leachables (E&L) across pharmaceutical products, packaging systems, manufacturing components, and drug-device combination products. In this expert Q&A, our expert discusses, key components, risk assessment principles, study design expectations and control strategies outlined in the latest draft guidance. Discover how pharmaceutical developers can prepare for evolving regulatory expectations, strengthen patient safety, and build robust E&L programmes throughout the product lifecycle.
Complete the form to access Intertek's expert Q&A and learn how the draft ICH Q3E guideline may impact your products, packaging systems and manufacturing materials now:
Intertek Pharmaceutical Services India
Analytical Testing, Auditing and Process & Powder Safety Testing US FDA, MH-FDA, CDSCO, cGMP, GLP & NABL Certified Laboratory
Intertek Pharmceutical Services India
F-Wing, Tex Center, Chandivali Farm Road,
Chandivali, Andheri (E) Mumbai,
Maharashtra - 400072
T: +91 1246 703703
T: +91-22-4245 0100
E: pharma-asia@intertek.com
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