Have you validated your water system?

Water is a versatile component used in the pharmaceutical industry.  It can be used as a raw material or solvent in the processing, formulation, and manufacturing of active ingredients, and final drug products.  It can also be used as an analytical reagent in the testing of products.  Whatever the use, you must validate your water system for its intended use.

validating water systems

A company recently received the following 483 observation:

…. A process whose results cannot be fully verified by subsequent inspection and test has not been adequately validated according to established procedures.

Specifically, the … purified water system has not been adequately validated. Purified water is used for formulation of … and for some manufacturing equipment of these products. Process validation was not adequately validated as follows:

a.         PQ Protocol … for the validation of the … water system stated that source water testing was to be performed … of the validation. After completion of … testing, testing a trend analysis between … water source to the facility and … source water to the water system was to show an acceptable confidence level and testing at site … was to be dropped to … The … sampling at site … was made from … to …. The validation report does not include a report of a trend analysis between port … and …. Test data indicates microbial levels sampled at … were significantly higher than …. Testing made on … found levels of 695 CFU/l00mL from … and 3 CFU/l00mL from … water. Testing made on … identified a level of 465 CFU/100mL at … and a level of 2 CFU/l00mL from … water. There was no documentation that the elevation in microbiological load in the source water was investigated.

b.         Water System Validation protocol … did not specify the frequency or type of chemical sanitization to be made during the validation. During the Process validation a … sanitization was made by the water system supplier. There is no documentation of a … sanitization being made during routine system use.

For more information on water systems refer to WHO guidance document, WHO good manufacturing practices: water for pharmaceutical use and FDA guidances, Water for Pharmaceutical Use and High Purity Water Systems.

To view more observations pertaining to water systems, refer to the following GMP Trends® Issues:  1078, 1077, 1076, and 1070.

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