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
