The "EMA Guideline on the quality of water for pharmaceutical use" states that for parenteral preparation, water of grade no less than WFI should be used for parenteral formulations. However, the vast majority of suppliers of WFI, in quantities larger than 1L, have statements on their products to say that they are not intended for direct human use.
If a product meets the relevant monograph requirements, but does not have a statement for use in humans (or QP released), is this suitable for use in a final parenteral drug formulation? If not, why?
- Badges
- Science topic
- Similar topics
- Higher Education
- Universities
Similar questions and discussions