The update reflects the following changes in the European Pharmacopoeia:
According to EMA, the overall intention behind the guideline is to support the pharmaceutical industry on the pharmaceutical use of different grades of water in the manufacture of APIs and medicinal products. The different grades of water should not only be discussed in the MAA, but also take account of the nature and intended use of the finished product and the stage at which the water is used.
Chapter 5 “Quality of Water for Pharmaceutical Use” offers tables of examples including
The document also applies to ATMPs (Advanced Therapy Medicinal Products). Where relevant, the principles of this guideline can be applied to investigational medicinal products, as well. According to EMA it should be considered for new marketing authorisation applications and for any relevant variation application to existing marketing authorisations.
The guideline does not 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 haemodialysis solutions) or in the case of veterinary products.
It compliments the “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 GMP/GDP Inspectors Working Group.”
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