As with any other equipment, it is important to work with the water purification system manufacturer to determine the appropriate
qualification protocols, how to carry them out, and an appropriate requalification schedule. The manufacturer's knowledge
can be crucial, especially if they have developed specific documentation to assist with validation procedures. In addition
to meeting cGMP requirements, this documentation also should be applied to each qualification stage and offer users comprehensive
help in conducting system qualification.
The engineers who deploy system qualification protocols should be trained in validation procedures and familiar with production
processes and regulatory requirements in the pharmaceutical industry. Furthermore, preventive maintenance helps ensure that
the water purification system is kept in optimal condition and prevents down-time.
Validation Parameters
Since the system qualification begins at the design stage, it is important to have a qualification team involved in the development
of all new systems. This enables the manufacturer to incorporate the pharmaceutical requirements for system design and specifications.
An important parameter to be considered for the qualification of water purification systems is the calibration of measuring
instrumentation. The product water should be monitored continuously for conductivity and, if required, total organic carbon
(TOC) levels using calibrated instrumentation. Water purification systems should be designed specifically to meet USP 28 <643>
and <645> suitability test requirements for TOC and conductivity respectively. Also, as recommended by FDA, system alerts
should be implemented to warn users if the system is performing outside the pre-determined specifications. Additionally, systems
manufactured in an ISO 9001/ISO 14001 certified plant permit good traceability. Certificates of Conformity, Certificates of
Quality, and Certificates of Calibration also should be available.
The USP specifies that operational qualification protocols be performed on-site after the system has been installed to meet
USP validation requirements.
Conclusion
Equipment validation is essential. Determining what equipment needs validating starts with ascertaining the requirements of
the end user. It then proceeds to a risk analysis with careful attention paid to regulatory requirements. Careful choice of
an equipment manufacturer that offers a comprehensive validation services program, incorporating specially-trained personnel,
on-site qualification protocols, calibrated measuring instrumentation, and the relevant documentation in accordance with GMP
requirements can facilitate the validation process and overall regulatory compliance.
Sean Murphy is worldwide validation product manager for the Lab Water Division of Millipore Corporation, Boîte Postale 307, 78054 St.
Quentin en Yvelines Cedex, France, (33)1.3012.7232, sean_murphy@millipore.com
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