ICH Q3E Guideline for extractable and leachables

Regulatory
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We in chemicals plant API, checking the last guideline from ICH Q3E if there are some issues might be related to our plant, the title for last guideline is (GUIDELINE FOR EXTRACTABLES AND LEACHABLES)

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ICH Q3E is the new, harmonised risk-based guideline for Extractables & Leachables (E&L). It sets out a lifecycle/QRM approach (materials characterization → extractables → targeted leachables testing → toxicological evaluation and control), and is intended to clear up the current international inconsistencies so industry and regulators have a common framework.

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ICH Q3E Extractables and Leachables – Scientific Guideline

  1. What Is It?
  • A new global guideline for checking tiny chemical impurities (extractables & leachables) that can come from packaging or equipment into medicines, including APIs.
  1. Why Care?
  • These impurities can affect medicine safety and quality. So, we need to find and control them to protect patients.
  1. Extractables vs Leachables:
  • Extractables = Chemicals pulled out under tough lab conditions (like a stress test)
  • Leachables = Chemicals that actually move into the drug during real use/storage
  1. How It Works:
  • Risk-based approach: Decide when testing is needed based on product type, dose route, and exposure.
  • Use chemical testing and analysis to identify and limit impurities.
  1. Status:
  • Draft guideline (Step 2b in ICH process)
  • Released for public review from August 18 to December 18, 2025.
  • Feedback helps shape the final rule.
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I would like to understand the relationship between this guideline and a chemical API manufacturing plant, considering that the plant produces drug substances intended for use in finished pharmaceutical products. Specifically, does the scope of this guideline apply to API manufacturers? Additionally, if the API plant performs impurity profiling—such as testing for elemental impurities, organic impurities, and residual solvents—would these activities fall under the guideline’s scope?
How can we determine whether E&L (Extractables and Leachables) testing is required for our product in an API manufacturing plant?

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This guideline is primarily focused on formulations; however, it may also apply to APIs that are highly potent or very sensitive and are stored for prolonged periods in plastic or elastomeric containers, where there is a risk of leachables.
Relevant only when packaging contact and risk factors are present.

Many of these rules are not directly applicable to intermediates and APIs, but customers often require compliance as a condition for supply. Therefore, we must be fully prepared and ultimately ensure that our products are safe from leachables and extractables.

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