Full gamut of CQV services
糖心Vlog has an extensive background in applying regulatory requirements, expectations, and standards on all projects. We provide the full gamut of CQV service offerings from conceptual design through handover and ongoing qualification and validation maintenance.
Our CQV services include:
- Design reviews/ qualification
- Factory acceptance test (FAT)/Site Acceptance Test (SAT)
- CQV document development
- CQV execution
- Current good manufacturing practices (cGMP) audits
Smooth transition from design to CQV
Embedding quality
Our CQV team works closely with engineering, manufacturing, procurement, quality systems, and construction to ensure quality is embedded in the project, user requirements are achieved in the design, regulatory concerns are addressed, and commissioning, and qualification needs are clearly communicated to the entire project team.
Ensuring compliance
We make it a priority to stay aligned with current pharmaceutical regulations, guidelines and client requirements and address them throughout design, construction and CQ phases. Using regular, formal current good manufacturing practice (cGMP) reviews, we document our compliance and prepare to defend regulatory agency submissions and inspections.
Full life cycle CQV approach
Early involvement of our CQV team ensures a smooth transition throughout each project phase. We follow the life cycle approach to commissioning, qualification and validation to define requirements during the earliest project phases, allow for a staged approach to qualification and achieve the best value.
