title: One-way distribution system for water for injection: process management, microbiological quality control, and meeting regulatory requirements.
abstract: The specifications for pharmaceutical water, the qualification and validation of water preparation facilities, strategies to prevent contamination by water-borne bacteria and lastly, the monitoring of microbiological purity are the topics of frequent seminars on Pharma Water Total Quality Management. The same subdivisions are used in the following paper on the process management and microbiological control of a one-way distribution system for Water for Injection. Since 1990, such a system has been in use in the production department of Pharma Hameln GmbH, a contract manufacturer of parenterals. Using this system as an example, the twin needs for flawless microbiological process control and for suitable measures to monitor water quality are discussed, which, together with extensive documentation of the qualification of the production and distribution system, ultimately led to acceptance of the system by regulatory authorities.
authors.affiliation: Pharma Hameln GmbH, Quality Assurance-Microbiology, Langes Feld 13, D-31789 Hameln. m.jahnke@pharma-hameln.de
authors.forename: M
authors.initials: M
authors.lastname: Jahnke
mesh_terms: D004339:Drug Compounding / Q000379:methods* / Q000592:standards; D004340:Drug Contamination / Q000517:prevention & control*; D007880:Legislation, Drug; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control; D013242:Sterilization; D014881:Water Supply / Q000592:standards*
chemical_list: D004364:Pharmaceutical Preparations