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Guidelines on quality of water for pharmaceutical use published by EMA

Updated: Dec 18, 2018

Draft guidance has been published by EMA on quality of water that has to be used for the pharmaceutical purpose. This draft will provide direction to the industry. This draft is aimed at providing knowledge about the pharmaceutical utilization of different grades of water used in manufacturing medicinal product and active substances for veterinary and human use. The methods which are parallel to the water distillation will be included in this draft. Advanced therapy Medicinal products, new marketing authorization, variation application to marketing authorization should also consider this draft guidance.


EMA's Committee for Medicinal Products for Human Use (CHMP) guidance on water for pharmaceutical use will be replaced by this draft. In addition to this "Position statement on the quality of water used in production on vaccines for parenteral use" and "Note for guidance on quality of water for pharmaceutical use” will also be replaced by this guidance. Changes will be reflected in the European Pharmacopeia also.

This guidance directs the prime updates in three monographs. The production of water for injection till mid 2017 was limited to production by distillation only. European pharmacopeia commission revised the European monograph, so the process parallel to distillation can also be allowed. Now the European pharmacopeia is more advanced and harmonious with US and Japanese Pharmacopeia.

The second monograph is the new one which contains the information regarding the water which is utilized for the preparation of extracts. It also contains information about the water used for the preparation of herbal based medicinal products.

This monograph will be put to an end; this has been decided by The European Pharmacopeia Commission.

The Monograph
The Monograph mentions that quality standard for three grades of water have been provided by European Pharmacopeia they are as follows:

a. Purified Water

b. Water for preparation of extracts

c. Pharmaceutical use that includes water for injection

This monograph also gives reference to potable water. European Pharmacopeia does not cover potable water; though it can be used for cleaning of medical equipment. It can also be used during the chemical synthesis for the medicinal product manufacture. The monograph provides information that EU directive 98/83/EC (Directive) is related to potable water which is utilized in the manufacture of medicinal products. The requirement for quality of water meant for human consumption is mentioned in the draft. This requirement should be kept in mind when using potable water for the manufacture of medicinal products.

Many tables describing the quality of water for pharmaceutical use have been included in the draft. General examples of direction are given in the table. It contains information regarding non -sterile medicinal products, sterile medicinal products and water utilized in the production of active substances and used for cleaning equipment.