Qualification of water system

Water used by pharmaceutical companies (for example, for manufacturing pharmaceuticals, cleaning the interior surfaces of equipment) directly affects the quality of the delivered products; qualification of PW and WFItreatment systems should be carried out in full (DQ, IQ, OQ, PQ). Besides, PW and WFI systems belong to systems operating in continuous mode, which requires regular monitoring of critical functions and parameters and periodic re-qualification. 

Qualification of water treatment systems is documented evidence that the water treatment system complies with GMP standards and other regulations. Validation must demonstrate that the water treatment system operates properly and consistently produces water of the desired quality. 

The key point of qualification of a water treatment system is that its testing is performed under conditions that imitate the routine process as closely as possible. We do not divide the sterilization of the tank and the loop, the collection of water, and imitation of its consumption into separate qualification stages; we test the whole cycle with mandatory load testing. 

We carry out all tests using wireless temperature, pressure and level data loggers, made of high-quality stainless steel, which will not introduce contaminants into your system. 

The qualification of water treatment may include qualification of utilities, purified water, water for injection, water production, storage and distribution systems. 

Qualification of water treatment systems, stages: 

  • DQ - Design qualification; 

  • IQ - Installation qualification; 

  • OQ - Operation qualification; 

  • PQ - Performance qualification; 

  • Justification for monitoring system; 

  • Selection of frequency and methods of preventive maintenance and sanitation. 

The qualification of water treatment systems is performed according to the following standards: 

  • FDA Guide to Inspections of High Purity Water Systems; 

  • ISPE Baseline Pharmaceutical Engineering Guide, Volume 4: Water and Steam Guide; 

  • PI 009-3 “Ide-Memoire inspection of utilities; 

  • PDA Technical Report No. 4 Design Concepts for the Water for Injection System; 

  • WHO Good Manufacturing Practices, Annex 3: water for pharmaceutical use. 

* WFI (Water For Injection) system is the system for the production, storage and distribution of water for injections. 

 PW (Pure Water) system is the system for the production, storage and distribution of purified water. 


For more information on water treatment system qualificationplease contact us in whichever way is most convenient for you. 

GMP water treatment system tests using high-precision wireless data loggers

Start cooperation

The guarantee of high-quality products and services!