Water
Article 14
1. Water used in the manufacturing process of active substances shall be suitable for its intended use. 2. Water used in the manufacturing of active substances shall be at least of drinking water quality, unless otherwise justified. 3. When drinking water quality is insufficient to ensure active substance quality and more stringent water quality specifications are needed, appropriate specifications for physical, chemical, microbiological attributes, objectionable organisms, and endotoxins shall be established. 4. Where water used in the manufacture of active substances is processed by the manufacturer to achieve a defined quality, the process applied to the water shall be validated and monitored and action limits shall be set to ensure the quality of the water. 5. Water used in the final isolation and purification steps in the production of a non-sterile active substance intended for the production of a sterile veterinary medicinal product, shall be monitored and controlled for total microbial counts, objectionable organisms, and endotoxins.