Qualification and validation
Related services
Qualification and validation are regulatory requirements as well as part of good business practices. Xendo covers the fields of product & process development, manufacturing and QA/QC. Our integrated approach ensures that the required qualification and validation status of your facilities, utilities, equipment, processes, analytical methods and products are met.
Contact qualification and validation
Jos van der Lubbe, business unit manager
- Telephone: +31 (0)71 524 40 00
- Email: jos.van.der.lubbe@xendo.com
Scope of services qualification and validation
- Designing Validation Master Plans
- Executing VMP / hands-on validation support
- Hands-on qualification of facilities, utilities and equipment
- Process and product validation
- Cleaning validation
- Validation of automated systems (21CFRpart11, GAMP)
- Validation of analytical methods (compendial/ICH)
- Operator qualification (aseptic production techniques)
- Risk assessment and risk control
- Training
