reworking
- Guideline or reference source
- ECA GAMP5 Approach and Risk Management
- ICHQ7 Good manufacturing practice for active pharmaceutical ingredients
- Definition
- Subjecting an intermediate or API that does not conform to standards or specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality intermediate or API (e.g., recrystallizing with a different solvent).
Send comments to info@celegence.com Please read disclaimer before using Qsauri.