Qualifizierung pharmazeutischer Wasseranlagen
Kristina Schlegel, Peter Bappert, gempex GmbH, Mannheim
Korrespondenz: Peter Bappert, gempex GmbH, Besselstr. 6, 68219 Mannheim (Germany), e-mail: public-relation@gempex.com
Validation of Pharmaceutical Water Systems / Requirements and practical experience
Water is one of the most important raw materials in pharmaceutical industry and is used for different applications. Water quality is of vital importance and is defined by limits for different chemical and microbiological impurities which have to be met demonstrably. Due to water being susceptible to microbiological contamination and variability in water quality, quality problems occur frequently, leading to consequences culminating in product recall. GMP Guidelines describe how to avoid such quality problems and characterise the requirements for high purity water systems in detail. In addition to the respective FDA, EMEA, PIC/S and ISPE Guidelines the pharmacopoeia monographs also inform about the requirements on production of water.To prove that a water system is capable of constantly producing water of the desired quality, water systems have to be validated, which is explicitly requested by the guidelines. Besides the usual requirements on validation there are some test points which need special attention during validation of water systems. This applies mainly to the so called performance qualification (PQ). For water systems it is characterised by the exceptionally long duration of a whole year. During this year three PQ phases are passed in which samples are taken and analysed in predefined intervals. After the end of validation water quality is further on monitored continuously. Practical experience shows that during validation of water systems problems often occur in the formal course of validation. For example, acceptance criteria are not defined precisely, documentation is incomplete, critical components are not specified sufficiently or interfaces have not been clearly differentiated. A systematic approach to validation helps prevent many mistakes. The following paper describes the requirements on validation of water systems, shows the most frequent mistakes and gives advice on how to prevent them. Key words Qualifizierung • Reinstwasser • Validierung • Wasseranlagen |
