Quality Control
Quality Control services range from providing interim management and oversight of your QC department to completing key projects. Here are some of the services Pacific BioDevelopment offers in this arena:
- Audit raw material vendors and testing facilities.
- Develop process controls and product specifications.
- Design the stability program suitable for your product and its stage of development.
- Establish reference materials.
- Evaluate test methods and methods validation.
- Assess laboratory controls and compliance.
- Provide interim management and oversight for clients without internal staff.
Validation
Validation services include developing master plans, protocols, summary reports, as well as regulatory submissions. Here are some of the services Pacific BioDevelopment offers in this arena:
- Design Phase-appropriate validation strategies for new products, processes, and facilities.
- Evaluate existing validation programs against current regulatory expectations and guidance documents and develop strategies to achieve compliance.
- Benchmark against current industry practices for validation including risk-assessment and implementation of Quality by Design (QbD) concepts.
- Provide training and conduct mock audits in preparation for regulatory inspection.
- Provide interim management and oversight for clients without internal staff.