FDA Inspectional Approach, Paul Bellamy (733 KB)
FDA Inspectional Approach, Paul Bellamy (733 KB)
FDA Inspectional Approach, Paul Bellamy (733 KB)
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AREAS TO LOOK FOR DEVIATIONS<br />
• MANUFACTURING<br />
AREAS<br />
• LABORATORIES<br />
• VALIDATION<br />
STUDIES (PROCESS<br />
AND METHODS)<br />
• EQUIPMENT<br />
QUALIFICATIONS<br />
• CALIBRATIONS<br />
• WATER SYSTEMS<br />
• HVAC SYSTEMS<br />
• ENVIRONMENTAL<br />
MONITORING<br />
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