EAEU adopts common requirements to water for pharmaceutical use

Print 19 December 2017
GMP News

Common Requirements to Water for Pharmaceutical Use in manufacturing the medicinal products were adopted by the Board of the Eurasian Economic Commission (EEC) on December 13. The regulations define three categories of water quality.

The Common Requirements to Water for Pharmaceutical Use are changing the existing situation. They not only include common approaches to manufacturing of drugs in EAEU in terms of using the water with specified quality characteristics, but also harmonize the EAEU legislation with the laws of European Union and take into account the requirements of the World Health Organization.

Depending on the pharmaceutical use, the Requirements define three categories of water quality, including Purified Water, Highly Purified Water and Water for Injection. For example, the purified water can be used in cases when there is no need to comply with the sterility requirements. However, it should be produced from water that, at least, has the quality of drinking water established by the authorized body of a member state and meet the Pharmacopoeia requirements for chemical and microbiological purity. The water of highest quality for pharmaceutical use is the water for injection, which is used as a solvent in the preparation of relevant medicinal products. Such water must pass the tests conducted for purified water and meet additional requirements to the content of bacterial endotoxins (less than 0.25 IU/mL), specific conductivity and total organic carbon.

The recommendations of EEC Board will take effect six months after their publication.

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