Water is considered as a key ingredient in many pharmaceutical and life sciences operations. It is widely used as raw material, ingredient, solvent, active pharmaceutical ingredient (API), intermediate product, and in the formulation/manufacture of pharmaceutical products. To enhance the quality of the Pharmaceutical water, the EMA has updated the two-decades-old EMA's 'Note for Guidance on quality of water for pharmaceutical use'. The new set of guidelines will come into effect from February 2021.

The major concern behind the revision of the guidelines is to control the microbial quality of water, which is a key resource for the development and maintenance of water purification systems. The European Pharmacopoeia signifies quality standards for grades of water for pharmaceutical use that includes water for injections (WFI), water for preparation of extracts, and purified water. The guidelines are updated to reflect: 

  • Revised monograph for water for injections
  • New monograph for water for preparation of extracts 
  • Suppression of the monograph for highly purified water 

The new guidance also provide recommendations for the minimum acceptable quality of water to be used for different purposes and applications, i.e., for the manufacture of sterile and non-sterile medicinal products, active substances and cleaning/rinsing of equipment used for the medicinal products.

As the updated guidelines provide more inputs on new marketing authorization applications, variations to existing authorizations, and investigational medicinal products, it is of utmost importance for manufacturers to comply with the set standards. For a comprehensive gap-analysis and hassle-free submissions, consult a Regulatory expert. Stay updated and stay compliant.


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