Qualification is of great importance and a fundamental element for the quality of pharmaceutical products.
It is also a prerequisite for further validation work.
The activities around the qualification are:
What we do in qualification:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Preparing and working out qualification plans
- Risk assessment
- 21 CFR Part 11 analysis
- Change Control
- Develop and setting up final reports