Unit 8: Quality Control and System Suitability
This unit explains the role of Quality Control (QC) in analytical laboratories and the concept of System Suitability Testing (SST) as per USP <621>. It covers QC principles, SST parameters, documentation practices, and regulatory significance to ensure analytical reliability and compliance.
Quality Control ensures that analytical results meet predefined specifications and comply with regulatory standards. QC activities include method verification, instrument calibration, and routine checks to maintain data integrity and product quality.
Key Points
QC verifies accuracy and precision of analytical results.
Includes system suitability, calibration, and performance checks.
Critical for batch release and regulatory compliance.
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