26/27 January 2021
GMP News |
Harmonisation of Pharmaceutical Water Requirements in Pharmacopoeias Continues |
For paragraph <645> Water Conductivity a comment will be added, emphasising the advantage of using online measurement devices instead of off-line testing. This comment derives from FDA and fits to the authority's 20th century initiative. The same comment will be added to the TOC paragraph <643>. No change to test limits are proposed. For the informational chapter <1231> a passage for Pure Steam has been added, giving more information with regard to definition, usage and preparation of pure (or clean) steam for pharmaceutical use. Moreover, a new monograph for 'Water for Pharmacy Use' is under discussion within the USP. Prepared by: |