Cleaning Validation Services
Cleaning validation ensures that equipment-cleaning procedures accurately remove residue to predetermined levels of acceptability. We comply with inspection consistency and uniformity for the cleaning validation program with guidance from the FDA’s “Guide to Inspection of Bulk Pharmaceutical Chemicals” and the “Biotechnology Inspection Guide”.
VTI can help you with all aspects of your cleaning validation program. Our qualified validation consultants have the necessary expertise to develop and improve your cleaning validation methods and procedures. Before beginning our work, we will provide you with clear expectations and deliverables for each step and, of course, customize each process to meet your unique needs.
VTI’s cleaning validation services include:
– Cleaning cycle development and Process Performance Qualification
– Residue limit determination and acceptance criteria
– Analytical method development for residue detection
– Cleaning validation master plans and protocols
– Equipment-specific cleaning procedure validation
Frequently Asked Questions
What is cleaning validation?
Cleaning validation is documented proof that equipment-cleaning procedures reliably remove product residue, cleaning agents, and contaminants to predetermined, acceptable levels. It prevents cross-contamination between production runs.
Why is cleaning validation required?
Regulators require it to ensure that residues from one product don’t contaminate the next, protecting patient safety and product integrity. VTI follows FDA guidance including the “Guide to Inspection of Bulk Pharmaceutical Chemicals” and the “Biotechnology Inspection Guide.”
What does a cleaning validation program involve?
It involves developing and validating cleaning procedures, setting residue acceptance limits, developing analytical methods to detect residues, and documenting that the cleaning process consistently meets those limits.
Can VTI improve an existing cleaning validation program?
VTI’s validation consultants develop new programs and improve existing cleaning validation methods and procedures, providing clear expectations and deliverables for each step.
