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Our specialists will carry out a one day,
baseline review of your
system/process to provide an overview and report of performance,
compliance and management issues, benchmarked against current industry best practice
and cGMP.
The System Health Check
will provide information regarding compliance with cGMP, other regulatory
guidelines and expectations, 'industry best practice' and other relevant
standards and guidelines, according to the best professional judgement of the
Honeyman Group Ltd.
The System Health Check
may typically include:
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An overview of the
System, Quality and Pharmaceutical Usage - examining; system
design, system performance (quality, consistency, operation and reliability), maintenance and control.
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An overview of System
Documentation
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confirming the existence and relevance of historical
validation data, SOP's, plant records and logs.
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An overview of any
associated
Analytical Processes
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including; chemical, microbiological and endotoxin
sampling and testing regimes, data review, out of
specification results/actions and management structure
and responsibilities.
Following a Honeyman System
Health Check, we will be able to help you:
Our health check will give you and your system the
following benefits;
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Independent expert opinion and benchmarking within
the industry.
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Identify potential financial and operational benefits.
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A better understanding and improved compliance confidence in
your system and its operation.
Systems and processes recently assessed include:
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