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GMP and GLP Auditing
ComplianceNet can provide a full
review of a facility, product line, or system to determine its
compliance with applicable regulations. Our recommendations
draw from both FDA and Eurpoean regulations and guidelines to
assure your firm will be compliant on a global scale. The
report we issue following an audit is much more than a check list
of findings. Each item is prioritized, so you will know
where to put your efforts first as well as the risk the item
poses. Each item is explained in detail, including what was
found, why it is not in compliance, and when possible examples of
ways the situation can be corrected. A full list of
references is included for further research. The specific citation for which
regulation or guideline resulted in the observation is
provided. Our reports stand above the rest!
We perform all types
of audits:
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General GMP |
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General GLP |
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Inspection Readiness |
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Contract Manufacturing
Organizations |
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Contract Laboratories |
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Raw
Material Vendors |
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Computer System Suppliers |
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Equipment Suppliers |
Contact
Us for More Information |
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FDA
Interpretation
Systems Based Inspections |
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As in the past, the [inspection] depth
will be determined by the significance of the findings.
Deficiencies found in a system may indicate deficiencies
in other systems. This may warrant expansion of
[inspection] coverage to varying degrees of other
systems.
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Operating under a State
of Control produces finished drug products for which
there is adequate level of assurance of quality,
strength, identity and purity.
Any one system out of control means
the firm is out of control.
Robert C. Coleman, FDA
PDA Presentation
October 2002
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