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…
Short answer A UV-Visible spectrophotometer is released for GMP use through four documented stages — design, installation, operational and performance qualification — and it is the operational qualification that carries the numbers most analysts are looking for: wavelength accuracy, control…
In one line: a stability chamber holds a fixed temperature and relative humidity by running conditioned air in a continuous loop past a heater, a refrigeration coil and a humidifier, with a PLC trimming each one against sensors mounted in…
Answer first Three pharmacopoeias describe the same measurement and they are not interchangeable. USP General Chapter <791> pH, Ph. Eur. 2.2.3 and IP 2.4.24 do not appear on either of the Pharmacopoeial Discussion Group harmonisation tables that USP publishes, so a…
Direct answer Sterilization kills organisms. Depyrogenation destroys or removes the endotoxin those organisms leave behind. A dead Gram-negative cell still carries the lipopolysaccharide that causes a pyrogenic response, so a container can be sterile and still fail a parenteral release…
In one paragraph Gas chromatography separates a mixture by repeatedly partitioning volatile components between an inert carrier gas (the mobile phase) and a liquid or solid film coated inside a capillary column (the stationary phase). Components that spend more time…
Short answer An SOP for fumigation of microbiology lab is only defensible if the cycle is validated and if re-entry is decided by a measured fumigant concentration — never by smell or by elapsed time. Fumigation is whole-room bio-decontamination, not…
The short answer Calibrating a volumetric Karl Fischer titrator means determining the water equivalence factor (F) of the titrant — how many milligrams of water one millilitre of reagent consumes. Sodium tartrate dihydrate is the standard of choice because it…