Cleaning Validation Protocol of Solution Preparation Tank

Cleaning Validation Protocol of Solution Preparation Tank [Pg.1045]

The purpose is to validate the cleaning procedure and ensure that residues of previous product are removed in accordance with the maximum allowable carryover limit calculated, as well as other tests, i.e., visual inspection, pH, conductivity, and TOC. [Pg.1046]

Quality assurance inspector/machine operator and QC analyst are responsible to follow the procedure. The quality assurance (QA) manager is responsible for SOP compliance. [Pg.1046]

Samples of the internal surfaces are taken by moistening the swab with a suitable solvent, sampling a 2.5-cm2 area, and then placing the swab in a test tube containing 10 ml of the solvent (specified for each active material from the analytical test method available in the laboratory or from pharmacoepia). [Pg.1047]

Big Chemical Encyclopedia