EMA: GL on bioanalytical method validation Rev.1 [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2014-09-19 19:09 (3478 d 20:04 ago) – Posting: # 13543
Views: 3,969

Dear all,

on Sep 15 EMA updated its Guideline on bioanalytical method validation.
The new document reference is EMEA/CHMP/EWP/192217/2009 Rev.1 Corr.*

Changes:
  1. Section 4.1.5. ‘Accuracy’
    • old
      […] around 50% of the calibration curve range (medium QC)
    • new
      […] around 30 – 50% of the calibration curve range (medium QC)
  2. Section 6 ‘Incurred samples reanalysis’
    • old
      The concentration obtained for the initial analysis and the concentration obtained by reanalysis should be within 20% of their mean […].
    • new
      The concentration obtained for the initial analysis and the concentration obtained by reanalysis should be within 20% of their mean […]. The following equation should be used for the cal­cu­lations:
                                 (repeat value – initial value)
           %difference = ──────────────────── ×100
                                            mean value
  3. Section 7.1.1.11. ‘Stability of the samples’
    • old
      In addition, long-term freezer stability should be studied at each temperature at which study samples will be stored. A bracketing approach may be considered.
    • new
      In addition, long-term freezer stability should be studied at each temperature at which study samples will be stored. A bracketing approach may be considered.
I’m fine with #1/#2. But why #3? If one has already shown stability at –80 ℃ and –20 ℃ – intending to store samples at any temperature in between – that’s an unscientific formalism, IMHO (yes; I’m aware about some Crystal City Conference discussions).
If you are referring to certain sections in your SOPs/protocols/reports (quoting a page-number), beware. The GL has been reformatted (now 23 pages instead of 22). :-D

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