Topical drug products and cosmetics are often manufactured in the same facility under a unified quality standard that supports the topical drug products’ performance and label claims. Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation.1
One of the goals of the cleaning validation design phase is to define critical process parameters (inputs) and acceptance criteria (outputs) of the cleaning process. This article explores the selection of a master soil as part of the cleaning validation design phase for automated parts washers. The selection and qualification of a master soil through laboratory testing and during factory...
It is a common practice in the pharmaceutical and biopharmaceutical industries to execute a factory acceptance test (FAT) for equipment involved with various drug manufacturing processes. The FAT is a project milestone in purchasing good manufacturing practice–compliant equipment.
What is cleaning validation and where does it fall in the life cycle validation scheme? How can an automated washing system be validated? This article provides insights that may help answer these questions.
