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cGMP Defined

 

 

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

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FDA Interpretation
Systems Based Inspections

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 


Copyright 2003 Compliance Net, Inc.

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