The
VTI team has successfully managed and executed Process Validations
on numerous manufacturing processes including:
- Active Pharmaceutical Ingredients
- Biotechnology
- Blood Facilities
- Liquid and Solid Dosage
- Medical Devices/Diagnostics
- Parenteral and Sterile Facilities
- Vaccine Manufacturers
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VTI has over a decade of experience
in successfully managing and executing Process Validation projects
worldwide – including Europe, Asia and the Middle East
as well as the United States and Canada. We deliver world class
service and industry wide best practice solutions to our clients
and ensure that their Validation process complies with regulatory
expectations – be they subject to regulation by the FDA,
EU, or other regulatory
Process Validation provides documented
evidence that a manufacturing process utilized consistently
produces a product meeting 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).
CPP’s are those processing variables, which must be
maintained in order to produce material consistently meeting
quality characteristics. CQA’s are predefined acceptance
limits that ensure the potency, safety and purity of the final
product.
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