Water Quality for Pharmaceutical Use: EMA Opens Consultation

Regulatory NewsRegulatory News
| 15 November 2018 | By Zachary Brennan 

With the aim of replacing guidance from 2002 on quality of water for pharmaceutical use, the European Medicines Agency (EMA) is offering new draft guidance for industry on the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary use.

EMA says the guidance should be considered for those submitting new marketing authorization applications (MAAs), as well as any variant applications to existing authorizations. The guidance also applies to Advanced Therapy Medicinal Products.

Water has many uses for the pharmaceutical industry, including for use as an excipient or for reconstitution of products, during synthesis, during production of the finished product or as a cleaning agent for rinsing vessels, equipment and primary packaging materials, among other examples.

“Different grades of water quality are required depending on the different pharmaceutical uses. Control of the quality of water, in particular the microbiological quality, is a major concern and the pharmaceutical industry devotes considerable resource to the development and maintenance of water purification systems,” EMA explains.

Validation and qualification of water purification, storage and distribution systems are a fundamental part of good manufacturing practices (GMP) and form an integral part of the GMP inspection.

The grade of water used at different stages in the manufacture of active substances and medicinal products should be discussed in the MAA, EMA explains, noting that the grade of water used “should take account of the nature and intended use of the finished product and the stage at which the water is used.”

The European Pharmacopoeia provides quality standards for the following grades of water, which are further outlined in the guidance: Water for injections; purified water; water for preparation of extracts.

The guidance also features 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; and water used for cleaning/rinsing of equipment, containers and closures.

EMA notes that the guidance is not intended to 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 hemodialysis  solutions”) or in the case of veterinary products. The guideline complements, “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 77 GMP/GDP Inspectors Working Group.”

The consultation ends 15 May 2019.

Guideline on the quality of water for pharmaceutical use: Draft


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Tags: EMA, guidance

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