Published 2025
Table of Contents:
“...Nethercote -- 20.1 Drivers for Change -- 20.2 Control of Change in the Pharmaceutical Industry -- 20.3 Implementing a Change -- References -- 21 Monitoring of Analytical Performance 487 Joachim Ermer -- 21.1 Sources of Performance
Data and Information -- 21.1.1 System Suitability
Test Parameters -- 21.1.2 Parameter from Calibration or Reference Standard Analysis -- 21.1.3 Parameter from Sample Analysis -- 21.1.4 Quality Control Samples (QCS) -- 21.1.5 Batch Results -- 21.1.6 Precisions from Stability -- 21.2 Systematic Monitoring
Program -- 21.3 Analytical Performance Evaluation Tools -- 21.3.1 Visualization Charts -- 21.3.2 Average Performance Parameters -- 21.4 Assessment of Analytical Performance -- 21.4.1 Immediate Actions -- 21.4.2 Analytical Performance Review (APR) -- 21.5 Conclusion -- References -- Index....
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