process robustness
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- ICHQ11 Development and manufacture of drug substances
- ICHQ8 Pharmaceutical development
- Definition
- Ability of a process to tolerate variability of materials and changes of the process and equipment without negative impact on quality.
Send comments to info@celegence.com Please read disclaimer before using Qsauri.