Process Validation

Process Performance Qualification

process-validationProcess Performance Qualification provides documented evidence that a manufacturing process 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). VTI has developed a product life cycle risk-based approach to process validation, from product development to end of product.  VTI approach to process validation is based on the FDA’s 3 stages of process validation.

VTI 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.

VTI is experience in developing process Validation Master Plans (pVMP) and protocols. Our process validation includes the following steps customized to your unique needs:

  • Sterilization Cycle Development and Process Performance Qualification
  • Cleaning Cycle Development and Process Performance Qualification
  • Disinfectant Efficacy Studies Development and Process Performance Qualification
  • Depyrogenation Cycle Development and Process Performance Qualification
  • Lyophilization Cycle Development and Process Performance Qualification
  • Biotechnology and Biological Upstream Manufacturing Development and Process Performance Qualification
  • Biotechnology and Biological Downstream Manufacturing Development and Process Performance Qualification
  • Medical Device Process Validation
  • Cannabis extractable and infusion Process Development and Validation
  • Herbal Medicines Process Development and Validation
  • Cosmetic Development and Process Validation

Cleaning Cycle Development and Validation

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.