Cleaning validation is a process to ensure that equipment cleaning procedures are removing residues to predetermined levels of acceptability.
The FDA’s “Guide to Inspection of Bulk Pharmaceutical Chemicals” and the “Biotechnology Inspection Guide” are designed to establish inspection consistency and uniformity for cleaning validation program.

Even today, many companies lack robust methods and/or rationale to address cleaning validation, and are therefore seeking validation consultants to help them develop/improve their cleaning validation methods and procedures.