Process Validation provides documented evidence that a manufacturing process utilized consistently produces a product that meets predetermined specifications. The process validation approach assesses critical unit operations at each step of the process, as governed by Critical Process Parameters (CPP’s) and Critical Quality Attributes (CQA’s).
VT has over a decade of experience in successfully managing and executing Process Validation projects worldwide – Europe, Asia, the Middle East, as well as the United States and Canada. We deliver world-class service and industry wide best practice solutions to you and ensure that your validation processes comply with regulatory expectations – be they subject to regulation by the FDA, EU, or other regulatory standards.
Successfully managed and executed Process Validations on numerous manufacturing processes including:
- Active Pharmaceutical Ingredients
- Liquid and Solid Dosage
- Medical Devices/Diagnostics
- Sterile Facilities
- Vaccine Manufacturers