NOVEX NOTES 186 / English
Independent analytical quality controls
Editorial educational material · 16 October 2026
Understanding the question
Control samples help evaluate performance beyond the arithmetic fit of calibration points. Their preparation and intended role matter. A check that simply repeats the same assumption may provide less independent information than its label suggests.
A worked example
Imagine a teaching calculation in which the expected answer and the checking value both come from the same mistaken entry. They agree perfectly, but the agreement cannot reveal the shared error. A reviewer therefore asks how the control values were assigned and how they relate to the calibration.
Original editorial teaching example, not clinical trial findings.What to check
Read the control strategy and source records. Do not equate repeated agreement with independent confirmation, and do not claim product content from an uncharacterised checking material.
Source and further reading
EMA — ICH Q2(R2) analytical validation ↗
Educational material. The source concerns the scientific topic, not NOVEX products. This article does not verify product properties or provide administration instructions. A short guide is not a systematic review.