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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TYPICAL PROBLEMS WITH<br />
INVESTIGATION<br />
• NO PRE-DEFINED RE-TEST PROCEDURES<br />
• ANALYST THOUGHT MISTAKE OCCURRED<br />
BUT CONTINUED TESTING ANYWAY<br />
• INVESTIGATION CONCLUDES<br />
PRODUCTION PROBLEM BUT NO<br />
PROBLEMS DOCUMENTED IN BATCH<br />
RECORD<br />
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