Extractables and Leachables Guidelines


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

EU regulation :

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:

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)



You can check Socosur Tox methodology for Extractables and Leachables Risk Assessments, signed by an European Registered Toxicologist expert here.

In the event you are performing this exercise for innovative compounds GMP scale up manufacturing, please be noted Socosur Tox is duly accredited for the French Research Tax Credit CIR.

Feel free to contact us using this email link to receive a quotation for Tox Extractables and Leachables procedure used on your manufacturing line.