[co-author: Alexander Wenzel]

Introduction

The EMA has published a draft Guideline on the quality of water for pharmaceutical use. The draft is intended to provide guidance to the industry. It concerns the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use. New methods that are equivalent to the distillation for water will be included in the guideline.

The guidance provided by the draft should also be considered for new marketing authorisations, variation applications to marketing authorisations as well as Advanced Therapy Medicinal Products.

The updates

The draft will replace the EMA’s Committee for Medicinal Products for Human Use (CHMP) guidance on water for pharmaceutical use. The two guidance documents that will be replaced are the “Note for guidance on quality of water for pharmaceutical use” and the “Position Statement on the Quality of Water used in the production of Vaccines for parenteral use”. The updates that this draft will bring reflect the changes in the European Pharmacopeia.

The draft addresses key updates concerning three monographs. Until mid-2017, the production of water for injections was limited to production by distillation only. The European monograph was revised by the European Pharmacopeia Commission[1], so processes equivalent to distillation could also be allowed. As a result, the European Pharmacopeia is more up to date and in line with the US and the Japanese Pharmacopeia.

The second monograph addressed, is the new monograph regarding the water used to prepare extracts. This monograph concerns water intended for the preparation of herbal based medicinal products.

The European Pharmacopeia Commission decided that this monograph will be suppressed on 1 April 2019.

The draft

The draft confirms that the European Pharmacopeia provides quality standards for three grades of water. Those are i) for pharmaceutical use including water for injections, ii) purified water and iii) water for preparation of extracts.

The draft also refers to potable water. Potable water is not covered by the European Pharmacopeia. However, it can be used to clean medical equipment. Potable water can also be used during chemical synthesis for the manufacture of medicinal products. The draft provides that EU Directive 98/83/EC (Directive) is applicable to potable water used in the manufacture of medicinal products. The Directive provides requirements for the quality of water intended for human consumption. These requirements must be complied with when using potable water for the manufacture of medicinal products.

The draft includes several tables concerning the quality of water for pharmaceutical use. The tables provide general examples for guidance. These concern sterile medicinal products, non-sterile medicinal products, water used during the manufacture of active substances and water used for cleaning or rinsing equipment.

Consultation deadline

The draft will be open for public consultation until 15 May 2019.

[1]               The European Pharmacopeia Commission is the decision making body of the European Pharmacopeia. The parent organisation of the European Pharmacopeia is the European “Council of Europe”. This is not an EU body. The contracting parties to the “Convention on the Elaboration of a European Pharmacopeia” take seat in the European Pharmacopeia Commission. The EU is one of those contracting parties.

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