Sterility testing is a mandatory microbiological quality control test performed to confirm the absence of viable microorganisms — including bacteria, fungi, and yeasts — in a drug substance, drug product, raw material, or bioprocessing component intended for parenteral or ophthalmic administration. Conducted under strict aseptic conditions in compliance with Ph. Eur. 2.6.1, USP <71>, and GMP guidelines, sterility testing is a critical batch release requirement for all sterile biopharmaceutical products, ATMPs, and viral vectors, and must be performed using validated methods with appropriate positive and negative controls.
