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EMA: Draft Guideline on the Quality of Water for Pharmaceutical Use

On 15 November 2018, the EMA has published a draft of the “Guideline on the Quality of Water for Pharmaceutical Use” for public consultation until 15 May 2019.

This 10-page document, once final, will replace the current “Note for guidance on quality of water for pharmaceutical use” from 2002 and the “CPMP Position Statement on the Quality of Water used in the production of vaccines for parenteral use".



The update reflects the following changes in the European Pharmacopoeia:

  • Revised monograph for Water for Injections (0169) allowing the possibility to use methods other than distillation for producing water of injectable quality
  • New monograph for Water for preparation of extracts (2249)
  • Suppression of the monograph for Water, highly purified (1927).

According to EMA, the overall intention behind the guideline is to support the pharmaceutical industry on the pharmaceutical use of different grades of water in the manufacture of APIs and medicinal products. The different grades of water should not only be discussed in the MAA, but also take account of the nature and intended use of the finished product and the stage at which the water is used.

Chapter 5 “Quality of Water for Pharmaceutical Use” offers tables of examples including

  • Water present as an excipient in the final formulation
  • Water used during manufacture of active substances and medicinal products excluding water present as an excipient in the final formulation
  • Water used for cleaning/rinsing of equipment, containers and closures.

The document also applies to ATMPs (Advanced Therapy Medicinal Products). Where relevant, the principles of this guideline can be applied to investigational medicinal products, as well. According to EMA it should be considered for new marketing authorisation applications and for any relevant variation application to existing marketing authorisations.

The guideline does not cover situations where medicinal products are prepared extemporaneously or where preparations are reconstituted or diluted with water prior to use by a pharmacist (e.g. water for reconstituting oral antibiotic mixtures, water for diluting haemodialysis solutions) or in the case of veterinary products.

It compliments the “Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies EMA/INS/GMP/443117/2017 GMP/GDP Inspectors Working Group.”


EMA: Open consultations

EMA: Draft guideline on pharmaceutical water

For the "Guideline on the quality of water for pharmaceutical use", line 48-55, It's difficult to understand the change. From my understanding, is it meant that there will be no Endotoxin requirement for the WFI, but rely on the products requirement?
Shen Yaohua 2018-12-04
Ph.Eur. revised the general chapter 5.1.10 inter alia regarding the test for bacterial endotoxines. Accordingly, the endotoxin limits have to be calculated product-specifically (if endotoxins are relevant at all) and defined by the pharmaceutical manufacturer himself using a risk-based approach. Thus, to our opinion, the test is not omitted, but you have to define the limits specifically according to your finished product.
GMP Publishing Editorial Office 2018-12-05
Literature recommendation
The New USP <1231>: Water for Pharmaceutical Purposes
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