Extractables and Leachables Guidelines

Regulation

ICH, Final concept paper/business plan: ICH Q3E Guideline for Extractables and Leachables (E&L), 30 June 2020
This includes process and product related substances (Q3A, Q3B), residual solvents (Q3C) and new guidelines covering elemental (Q3D) and mutagenic (M7) impurities.

Dates to remember:

In July 2020, The final concept paper and the Business plan were endorsed.
Between October 2020 and December 2021, 6 EWG Meetings are being held.

Future key dates :

May 2023: Step 1 Sign-off, Step 2a/b endorsed
May 2025: Step 3 sign-off and Step 4 Adoption of final guideline

Links to: Concept paper, Business plan and Work plan
https://database.ich.org/sites/default/files/ICH_Q3E_ConceptPaper_2020_0710.pdf https://database.ich.org/sites/default/files/ICH_Q3E_Business_Plan_2020_0710.pdf
https://database.ich.org/sites/default/files/Q3E_EWG_WorkPlan_2021_1216.pdf

EU regulation :

• EMA : Plastic and packaging impurities guidelines, 19 May 2005:

Committee for medical products for human use (CHMP), Committee for medicinal products for veterinary use (CVMP).
Plastic and packaging impurities guideline: Guideline 2005 on plastic immediate packaging materials.

• Union Guidance on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food as regards information in the supply chain.
• EudraLex: The Rules Governing Medicinal Products in the European Union, Volume 4
• EU Guidelines to Good Manufacturing Practice (GMP), Medicinal Products for Human and Veterinary Use: Annex 1, Manufacture of Sterile Medicinal Products
• ISO 10993-18: 2020 Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process. Ch 6. Chemical characterization parameters and methods: 6.3 Extractables and leachables

USA Regulation:

• FDA Guideline for Industry-Container Closure Systems for Packaging Human Drugs and Biologics (1999)
• USP (United States Pharmacopeia) General Chapters on Extractables and Leachables (USP 1663 & 1664)

There are also groups of experts, such as the 

• “PQRI” (Product Quality Research Institute),
• “PDA” (Parenteral Drug Association),
• “IPAC-RS” (International Pharmaceutical Aerosol Consortium on Regulation & Science),
• “ICH” (International Conference on Harmonisation, Q6A guideline); and
• “ELSI” (Extractables and Leachables Safety Information Exchange)