Our pharmacists, engineers and technicians can support the different departments of your company.
Quality Assurance / Quality Control
Elaboration or improvement of your Quality System
- Evaluation of quality systems
- Quality compliance evaluation of existing plants and installations
- Elaboration or revision of SOP’s or other quality documents
- Elaboration and follow up of preventive and corrective action plans
- Supplier audits
- Internal audits
- Preparation of audits from the international authorities
- Staff training
- QP services
Hygiene
Elaboration or improvement of your procedures
- Cleaning and disinfection of the clean rooms and equipment
- Gowning
- Material- and personal flow
- Staff training
Monitoring
From the simple advise to the complete performance of the monitoring
- Clean rooms
- Cleaning operations
- Process water (WFI, HPW, PW)
- Clean steam
- Gases (compressed air, nitrogen, O2, CO2)
- Staff training
Clinical trials
Support in the following areas
- GMP for the manufacture of investigational medicinal products
- Elaboration of IMPD’s
- Choice of contract manufacturing companies
- Supplier audits