Study Set: qc lec prelims

CGMP Inspection Coverage Examples

Actual conditions and practices
Raw Material Quality
State of maintenance of equipment, and facilities
Personnel -- Actual Operations, Procedures, Training
Changes in manufacturing and laboratory
Adequacy of design (discussed 18x in CGMP regulations)
Latest stability data
Process Implementation and experience
Process Validation, lifecycle improvements
Batch trends: latest in-process control data
Complaints, returns, deviations, failures, OOS and

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qc lec prelims

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