WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 14): Sterile Pharmaceutical Products
(2006; 62 pages)
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Sterile Production

Equipment (continued)

  • Water treatment plants and distribution system

    - design, construction, maintenance

    - operation and design capacity

    - testing programme

  • Water for Injection (WFI)

    - produced, stored, distributed - prevention of growth of microorganisms

    - constant circulation at temperature above 70, or not more than 4 degrees Celsius

Water of appropriate quality should be supplied by a water treatment plant that is suitably designed, constructed and maintained. You should evaluate the water treatment plant in terms of maintenance and qualification, as well as the monitoring of the quality of the water. The production, storage and distribution of water should be done in such a way that microbial growth is prevented. Evaluate the SOP for water sampling and review the results of the water testing. You should also check the deign of the water treatment plant, the distribution and storage of water. If water is stored in a tank, then the temperature should be kept at about 70 degrees Celsius.

Refer the participants also to the additional training module on Water systems.

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Última actualización: le 3 mayo 2013