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What is the significance of water quality in ensuring product quality and regulatory approval?
Water quality is a critical factor in ensuring the quality and safety of products.
In Germany, we are fortunate to have exceptionally clean and germ-free water. Our regular tap water meets drinking water standards nationwide, thanks to advanced water purification and treatment systems.
This is an important starting point for pharmaceutical production. The drinking water used for this purpose is further filtered and specially treated to meet the stringent requirements of pharmaceutical manufacturing. It is subsequently utilized in different grades — such as PW (Purified Water) or WFI (Water for Injection) — as a solvent, diluent, and for cleaning systems, containers, and laboratory equipment.
This shows the direct influence of water quality on the efficacy, purity and safety of medicines.
What quality standards and regulatory requirements must water comply with in the production of medicinal products?
Water used in pharmaceutical production must meet specific quality standards to ensure the safety and efficacy of medicines, as well as to prevent health risks.
The different types of water we use at Denk Pharma are:
1) Purified Water (Aqua purificata or purified water):
Used for the manufacture of non-sterile medicinal products such as tablets, capsules, ointments, or suppositories.
These products do not necessarily have to be free of microorganisms as long as they meet certain regulatory requirements for microbiological quality, in accordance with the European Pharmacopoeia (Ph.Eur.). This is ensured through hygienic production processes and well-managed quality controls, thereby guaranteeing the safety and efficacy of the products for patients.
2) Water for Injection (WFI):
Used for the preparation of injection and infusion solutions.
3) Highly Purified Water (Aqua valde purificata or highly purified water):
Used for the production of particularly pure medicinal products. Such as products with particularly high microbial and chemical purity requirements, but without strict sterility requirements, e.g. Diclofenac gels.
4) Ultrapure Water (UPW):
Used in sensitive pharmaceutical applications such as chromatography or analytical tests.
The European Pharmacopoeia also lists Sterile Water for Inhalation and Water for the production of purified steam – however, these types of water are not used in our production.
The production of water for pharmaceutical purposes follows the EU GMP guidelines, the Drinking Water Ordinance, and ISO standards.
