Darshan Singh

Darshan Singh

Author is a pharmaceutical quality and regulatory professional with more than 23 years in drug manufacturing. He holds an M.Sc. in Organic Chemistry and a Diploma in Pharmacy. He has served as Quality Control Head, Quality Assurance Head and Plant Head, overseeing all manufacturing operations. He is co-founder and regulatory consultant at Laafon Galaxy Pharmaceuticals. He writes on SOPs, manufacturing processes, Schedule M compliance and drug pharmacology, and checks each claim against pharmacopoeial and regulatory sources.

SOP for fumigation of Microbiology Lab

SOP for fumigation of microbiology lab

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…

Karl Fischer Calibration: KF Factor Limits + DST SOP

Karl Fischer titration cell diagram showing double platinum electrode, drying tube and burette

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…