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News about GMP/cGMP

2017-11-08

Purified Water Monography: New Draft in European Pharmacopoeia 9.4

A draft of the monography to Purified Water was published in the European Pharmacopoeia, which includes a new section on Elemental Impurities.

 

In line with the Ph. Eur. implementation strategy for the ICH Q3D guideline for elemental impurities, the test for heavy metals (2.4.8) has been deleted.

However, to retain the aspect of control for elemental impurities, the ‘Purified water in bulk’ section of the monograph has been revised to address the situation where purified water inbulk does not comply with the requirements for conductivity prescribed in Water for injections (0169) in bulk.

This is the new section on elemental impurities:

Elemental impurities: If purified water in bulk does not meet the requirement for conductivity prescribed for Water for injections (0169) in bulk, a risk assessment according to general chapter 5.20 Elemental impurities is carried out. The risk assessment should consider the role of water in the manufacturing process, in particular when water is used in a process but is no longer present in the final product.

Source:

EDQM: Comments concerning revised texts published in Supplement 9.4

Comments
Hello, I did not found that the appearance and nitrate level will not be tested anymore in the new monograph. Can you explain?
ana fritschy 2017-11-21
 
Sir, Madam, If I look at the online draft version of EP 9.4 I still see the Nitrates test and 'appearance' in the monograph. I do not see any exclusions not to test them? Also, when making WFI out of PW and nitrates testing is not required for PW anymore, is nitrates testing for WFI then required?
Rinke Nijland 2018-02-12
 
The red scissors in the online version of the PhEur 9.4 and 9.5 indicate that text was removed from that location in the monograph. As noted in Pharmeuropa 28.3, the text concerning Heavy Metals has been removed. This does not indicate that the Appearance and Nitrates tests will be removed, or that the Appearance and Nitrates tests do not need to be performed. Please refer to Pharmeuropa 28.3 on the EDQM website: http://pharmeuropa.edqm.eu/home/
Douglas Muse 2018-02-15
 
Thank you all for your comments. You are perfectly right. Sorry for our misinterpretation. We have already deleted the paragraph on appearance and testing of nitrates. The only changes in the monograph are the new section on elemental impurities and the parallel deletion of the test for heavy metals.
Editorial Office GMP Publishing 2018-02-22
 
 
 
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