Cleaning validation has emerged as a critical focus area in pharmaceutical manufacturing, particularly following heightened regulatory scrutiny through agency publications such as the Inspection Guide for Bulk Pharmaceutical Chemicals and the Biotechnology Inspection Guide. These guidelines explicitly state that cleaning procedures must be rigorously validated to ensure they consistently prevent cross-contamination and maintain product safety.

This document aims to promote consistency and uniformity in inspections by outlining practices that have been deemed acceptable—or unacceptable—in the industry. It is important to recognize that, as with other validation processes, there may be multiple scientifically sound approaches to cleaning validation. Ultimately, the success of any validation effort is determined by whether it provides scientific evidence that the cleaning process consistently performs as intended and delivers results that meet pre-established acceptance criteria.