Establishing acceptance criteria for analytical methods: Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge

BioPharm International

Volumn 29, Issue 10, 2016, Pages 44-48

  Little, Thomas A ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ACCURACY; ANALYTIC METHOD; ANALYTICAL PARAMETERS; KNOWLEDGE; LIMIT OF DETECTION; LIMIT OF QUANTITATION; LINEARITY; MATHEMATICAL PHENOMENA; MEASUREMENT REPEATABILITY; NOTE; RISK MANAGEMENT; ROBUSTNESS; SENSITIVITY AND SPECIFICITY; VALIDATION STUDY; VARIANCE;

EID: 85016481389     PISSN: 1542166X     EISSN: 19391862     Source Type: Trade Journal    
DOI: None     Document Type: Note

References (7)

1. ICH, Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (ICH, March 1999).
2. ICH, Q9 Quality Risk Management (ICH, 2006).
3. ICH, Q2(R1) Validation of Analytical Procedures: Text and Methodology (ICH, November 2005).
4. USP, <1033> Biological Assay Validation, USP 38 (USP, 2010).
5. USP, <1225> Validation of Compendial Procedures, USP 38 (USP, 2015).
6. FDA, Analytical Procedures and Methods Validation for Drugs and Biologics, Guidance for Industry (CDER, July 2015).
7. T. Little, Accuracy to Precision (ATP) Profiler, http://thomasalittleconsulting.com/tools/generalstatistics/index.php