Stay In Compliance with SANTE 2020/12830 Rev.1

Stay In Compliance with SANTE 2020/12830 Rev.1

There has been a change regarding the approved guideline for analytical method validation. This has been updated to  SANTE/2020/12830 Rev. 1 which now replaces SANCO/3029/99 Rev.4 & SANCO/825/99 Rev.8.1

This new guideline is effective from the 1st March 2021 and a transitional period has not been provided.
The Scymaris team have amended validation protocols in line with the new guideline to ensure studies initiated on or after this date will remain fully compliant.

This new update encompasses several changes and provides fresh guidance on the requirements for validation of analytical methods used in risk assessments. We have highlighted these below for your information:

  1. Matrix effects must be assessed.
  2. A representative aqueous media may be selected to cover multiple ecotoxicology and environmental fate studies.
  3. Low calibration standards must be 30% of the LOQ and residual plots for calibration must be provided.
  4. Mass spectra must be provided to justify ion selection.

Since the guideline SANTE/2020/12830 Rev.1 has already come into effect we would like to reassure you that we continue to be fully compliant.

Should you require any further information regarding this new guideline please do not hesitate to contact Magalie Ferbach by email : Magalie.Ferbach@scymaris.com or by phone on 00 33 6 13 61 70 33.

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