|
Honeyman Group
|
Water System Validation
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®.
As specialists in the field of water system validation we have a
range of knowledge and experience which is seldom available within
individual manufacturing companies. Our 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
Our involvement can range from the provision of a full system
validation package, including the development of procedures,
protocols and related documentation, to straightforward
implementation against existing procedures established by the
client. Typically, our service will involve on and off-site
work, regular performance reviews with the client and on-going
support for Continuous Compliance Assurance (CCA) which ensures the
water system is in a continuous state of inspection readiness.
Our 'life-cycle' system validation services include:
-
Development of Validation Master
Plan (VMP) and User Requirement Specification (URS)
Our experience and knowledge enable us to
write a VMP and URS to suit the regulatory needs of the intended
Purified Water / Water For Injection system
-
Design Qualification (DQ)
Taking inspiration from the URS, Honeyman
can develop a protocol intended to challenge the system design
-
Installation Qualification (IQ)
A protocol when completed ensures that the installation will
meet the requirements of the design
-
Operational Qualification (OQ)
A protocol when completed
defines that the built system fulfils the URS and the system
design intent
-
Performance Qualification (PQ)
-
All Phases
Our abilities allow us to define the method and
conduct
chemical and microbiological testing for the PQ1, PQ2 and
introductory PQ3 phases
-
On-Going Monitoring
Regimes (Continuous Compliance Assurance
or CCA)
Thus ensuring that the Purified Water /
Water For Injection system is capable of audit at any time
-
Validation Review
A Retro-validation exercise to determine
the condition of the system
-
Re-Validation
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
-
Change Control
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.
|
