By Darshan Singh, 23 years in pharmaceutical QC, QA and regulatory affairs. Clauses checked against the primary texts on 27 Sep 2026. Short answer Batch record review is the check, made for every batch before it is released, that the…
Short answer A conductivity meter is calibrated in two independent parts. First, the cell constant is established with a standard solution of known conductivity. Second, the meter electronics are checked against traceable precision resistors. For pharmacopoeial water testing, USP <645>…
In short Empty hard gelatin capsule shells are received, sampled and tested like any other drug component. QC samples each lot against an acceptance quality limit agreed with the supplier, sorts what it finds into critical, major and minor defects,…
Short answer A dissolution test assembly is calibrated in two parts. The mechanical part checks the assembly against the tolerances in the harmonised dissolution chapter: stirring element 25 ± 2 mm above the vessel bottom, shaft axis not more than 2 mm off the…
Short answer A fluid bed dryer (FBD) dries wet granules by blowing filtered, heated air up through a perforated screen fast enough to lift the bed, so every granule is surrounded by moving air. Drying stops when the loss on…
Short answer Pharmaceutical method validation is the documented proof that an analytical procedure is fit for its intended purpose: identity, impurity, assay or another quantitative test on a drug substance or product. Since 1 November 2023 the governing text is…
Short answer Under India’s revised Schedule M, every container of a starting material gets an identity test on its own sample. Clause 19.7.2 of Part I says so, and a smaller proportion may be sampled only where a validated procedure…
Answer first There is no current WHO or EU GMP requirement for 20 air changes per hour. The figure everyone quotes comes from WHO Technical Report Series 961, Annex 5 (2011), clause 4.1.6, where it reads “could normally vary between…
The short answer A control sample of finished product must be kept for at least one year after the expiry date, in its final packaging, in a quantity sufficient for at least two full re-examinations. All three of India, the…
Quick answer An FTIR spectrophotometer in a pharmaceutical QC laboratory is calibrated with a polystyrene film of about 35 µm: you check the wavenumber scale against seven polystyrene bands and the resolution against two band pairs. For FTIR calibration as…