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PDA Team Addresses Q&A Doc on Non-Distillation WFI

Jan 30, 2017

Last June, EMA published the draft document, Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies. EMA often uses such Q&A documents to clarify the Agency’s position, including possible regulatory requirements, in response to changes in directives, guidances, or in this case, a pharmacopeial monograph, specifically the European Pharmacopoeia’s (EP) Water for Injections (WFI) monograph (0169).

This revision has been long-awaited. The USP has allowed purification, along with distillation methods, to be used to produce WFI for many years, while the EP only allowed the use of distillation to produce WFI. Those in the pharmaceutical water community welcomed this revision with great excitement and optimism. In response to the EMA document, PDA assembled a team of PDA water experts to review and comment on it.

In its response, PDA fully supported the implementation of non-distillation methods for WFI production into the European regulatory framework, and endorsed the premise that non-distillation technology for producing WFI should produce water equivalent in quality to that produced by distillation.

The team had concerns with many of the approaches specified in the Q&A document, however, deeming them not science- nor risk-based. In fact, the team considered some of the requirements to be above and beyond what is in the EP monograph.

PDA recommended referencing existing technical documents, such as PDA’s technical reports for best practices, and allowing manufacturing firms to make risk-based decisions based on science instead of limiting firms through overly prescriptive regulations or monographs. The cited examples were rapid microbial methods and online vs. offline total organic carbon methods. The commenting team further stated that “this document should clarify monitoring methods which are reactive vs. control methods which are proactive.” Additionally, the team recommended including requirements for distribution and storage systems that permit manufacturers (as long as they include appropriate documentation) a choice of routine sanitization approaches, such as steam, hot water, ozone, or other chemicals, and avoid requiring complete redundant approaches or steam in all cases.

Read the commenting team's letter to EMA here.


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