Short answer A sanitizing solution is a disinfectant concentrate diluted to a fixed, validated in-use strength. A common error in published SOPs is writing the dilution as a volume of stock without stating the stock’s strength. Forty millilitres of hydrogen…
By Darshan Singh, QA/QC and regulatory practitioner (23+ years). Rebuilt 3 October 2026 against the notified Revised Schedule M text. Short answer Pest control in a pharmaceutical plant is a written GMP obligation. Revised Schedule M requires premises that keep…
By Darshan Singh, 23 years in pharmaceutical QC, QA and regulatory affairs · Reviewed against the source texts on 29 September 2026 Short answer Validation is documented evidence that premises, utilities, equipment, processes, cleaning procedures, test methods and computerised systems…
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…