Quality of Water for Pharmaceutical Use – ISPE Video
This training is intended to provide guidance to the audience on the pharmaceutical use of different grades of water from a European regulation perspective. The control of the microbiological quality of water is extremely important. A marketing authorization application must provide information regarding the grade of water used at different stages in the manufacturing.
The European Pharmacopoeia outlines quality standards for different grades of water. Due to the fact that the now outdated guideline was adopted in 2002, there was a need to be in line with recent revisions made to the European Pharmacopoeia. The new version reflects the changes in the following three monographs:
- Revised monograph for Water for Injections (WFI): this revision allows for production of WFI by a purification process equivalent to distillation such as reverse osmosis, coupled with appropriate techniques. This brings the Ph. Eur. more closely aligned to the USA and Japanese Pharmacopoeia;
- New monograph for Water for preparation of extracts;
- Deletion of monograph for Water highly purified.
Stephan Neumann
Stephan has a M.Sc. In Utility Engineering and is pursuing a M.Sc. in Pharmaceutical Microbiology. He works for Boehringer Ingelheim since 2002 and his role is ” Global Governance Pharmaceutical Water Systems”. He is providing support to all production sites in the network. This encompases hands-on site support, audit (response) support, trouble shooting, training, site improvements and much more.
He is a member of the ISPE D/A/CH Critical Utilities group. He did contribute to the ISPE Handbook “Production of Water for Injection without Distillation”, which goes into multiple ways to produce WFI acc. to European regulations.
Stephan is also a member of the EDQM Water Group. This group is responsible for the water monographies in the European Union.