Quality control
Support for establishing and strengthening laboratory quality control.
The CHMP supports medicines quality control laboratories in setting up, organising and improving their operations. This support focuses on staff skills, analytical methods and the reliability of results.
Establishing laboratory quality control
Support is tailored to the laboratory’s needs and resources. It may cover:
- organising analytical activities;
- implementing good laboratory practices and quality documentation;
- qualifying and maintaining equipment;
- validating and transferring analytical methods.
Strengthening practices and skills
The CHMP provides support with managing raw data and out-of-specification results, preparing self-inspections and training staff in analytical techniques and the use of equipment.
ISO 17025
Support to understand the standard and prepare a fit-for-purpose approach for laboratory needs.
This service supports understanding ISO/IEC 17025 requirements and structuring an appropriate implementation pathway.