With the follwing services, we are able to provide support during the WHO prequalification procedure
- Guidance for elaboration of the PSF (product summary file) and PSF review
- Inspection and gap analysis for existing facilities to assure compliance with WHO GMP guidelines: Clean room layouts and construction, material / personnel / product flows, design of the utility systems, etc.
- Training on shipment validation and other topics
- Review of quality control procedures and stability studies
- Preparation of the WHO site audit