Thursday, June 11, 2009
VALIDATE WATER SYSTEM
All pharmaceutical water systems delivering Purified Water, Water Highly Purified or Water for Injection must be validated to demonstrate that they meet, and will continue to meet, their quality specification as laid down in the monographs of the relevant pharmacopoeias (USP or EP/PhEur), their requirements, as laid down in the User Requirement Specification (URS) and the requirements of the ISPE Baseline Pharmaceutical Engineering Guide®.
water system validation we have a range of knowledge and experience which is seldom available within individual manufacturing companies.
aim is to provide a comprehensive validation service which ensures regulatory compliance is achieved quickly and cost-effectively, ensuring full traceability.
Prospective Validation for New Pharmaceutical Water Systems
FOLLOWING POINTS SHOULD BE COVERED.
Development of Validation Master Plan (VMP) and User Requirement Specification (URS)
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ) - All Phases
*conduct chemical and microbiological testing for the PQ1, PQ2 and introductory PQ3 phases
On-Going Monitoring Regimes (Continuous Compliance Assurance or CCA)
A Retro-validation exercise to determine the condition of the system
The production of protocols and the re-validation of the system ensure that any changes made to the system are captured and that the system is inspection ready
Inauguration of a change control procedure to ensure compliance of any system change
Retrospective Validation for Existing Pharmaceutical Water Systems
The industry is required to maintain water systems in a validated state, operating under proper procedures with full water system documentation, maintenance and management control, that is supported by an appropriate monitoring regime.
There are occasions, especially if there have been system modifications or alterations, when it is necessary to carry out a retrospective validation. Unlike generic validation houses, which lack industry specific knowledge and assess the water system against today's standards and criteria (often resulting in unnecessary system re-build and expense), our approach is to evaluate the system according to its age and design principles and retrospectively validate only to critical parameters.