EMA: New guideline on the quality of water for pharmaceutical use
On 20 July 2020, EMA published the final 10-page Guideline on the quality of water for pharmaceutical use.
The date of entry into force will be 1 February 2021.
On that date the guideline replaces
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the Note for guidance on quality of water for pharmaceutical use from 1 May 2002
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the CPMP Position Statement on the quality of water used in the production of vaccines for parenteral use from 20 October 2003.
It takes into account the following interim changes to the European Pharmacopoeia:
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the revised monograph on Water for Injection (0169), which offers the possibility of using processes other than distillation for WFI (Water for Injection), e. g. reverse osmosis
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new monograph on water for the production of extracts (2249) and
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the suppression of the monograph for HPW, highly purified water (1927)
It also reflects the expectations for the minimum acceptable water quality in the manufacture of active ingredients and medicinal products for human and veterinary use.
The guideline is to be understood as a guideline for the pharmaceutical use of different water qualities in the manufacture of active substances and medicinal products for use in human and veterinary medicine. The document also applies to ATMPs (Advanced Therapy Medicinal Products) and can in general also be applied to investigational medicinal products (IMPs).
Chapter 5 “Quality of Water for Pharmaceutical Use” contains tables with examples for different water qualities such as
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Water present as an excipient in the final formulation
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Water used during manufacture of active substances and medicinal products excluding water present as an excipient in the final formulation
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Water used for cleaning/rinsing of equipment, containers and closures
Read the new guideline together with the corresponding Q&A paper “Questions and answers on production of water for injections by nondistillation methods – reverse osmosis and biofilms and control strategies". This Q&A was published in 2017 after the revision of the WFI monograph.
Source:
EMA: Guideline on the quality of water for pharmaceutical use
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