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…
Direct answer A polarimeter is calibrated by checking its scale accuracy against a certified quartz control plate and its scale linearity against sucrose solutions of known concentration, then comparing each reading with the value that standard is certified to give…
The short answer The harmonised pharmacopoeial method specifies exactly one thing about how long a friability test runs: 100 revolutions of a drum turning at 25 ± 1 r The “4 minutes” printed in most Indian SOPs is arithmetic (100…
Working standard in pharma: the short answer A working standard is an in-house lot of a drug substance that a Quality Control laboratory uses in place of the official reference standard for routine testing. Indian GMP calls it a secondary…
Updated 11 September 2026 · By Darshan Singh, former QC Head, QA Head and Plant Head · Reviewed against primary pharmacopoeial and GMP texts Short answer Liquid filling machine validation is the documented evidence, built through design, installation, operational and…