Cleaning Validation (Dosage-Wise)

Cleaning Validation (Dosage Wise) is the documented proof that cleaning procedures remove product residues, cleaning agents, and bioburden to acceptable limits—specific to the risks of each dosage form. Powders and granules may lodge in hard-to-reach areas, ointments and creams can leave persistent films, liquids can create drain-line and hose residues, and sterile products add tighter microbiological and endotoxin expectations. This category explains dosage-form-specific worst-case selection, acceptance limits (MACO/HBEL where applicable), sampling methods (swab/rinse), cleaning cycle development, visual inspection criteria, analytical method suitability, equipment train mapping, and routine monitoring—aligned with FDA expectations, EU GMP, and modern toxicological approaches.