Plain-language explanation, inspection context and common violation patterns.
This chapter provides guidance on weighing with an analytical balance, covering the choice of balance, its location and installation, calibration, qualification, routine performance checks, and good weighing technique. It addresses environmental effects such as drafts, vibration, temperature and static, and the minimum weight below which results are not reliable.
Paraphrased for plain-language clarity. Always verify against the current published regulation text.
Weighings recorded on a balance with no evidence of a routine check on that day, or amounts below the balance's minimum weight.
GMPify's Regulation Explainer tool gives subscribers an AI-powered analysis of any 21 CFR, EU GMP, USP or ICH reference, with live inspection context.
Try the Regulation Explainer →