Continued Process Verification

Scherder, Tara; Giacoletti, Katherine E.D.

doi:10.1201/9781315120034-8

Cited by 1 publication

(1 citation statement)

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“…It should be noted that CLIA-specific trending recommendations have been provided by the agency, and to an extent, they are also applicable to LBAs as CLIA also calls for multiple runs with multiple QC sets over multiple days and by multiple analysts. QC trending may be real-time or indirect; Scherder and Giacoletti (16) have discussed the difference between the two approaches. Most SPC tools are designed to detect shifts early enough so that appropriate corrective actions may be devised and implemented.…”

Section: Qc Performance Trendingmentioning

confidence: 99%

Quality Controls in Ligand Binding Assays: Recommendations and Best Practices for Preparation, Qualification, Maintenance of Lot to Lot Consistency, and Prevention of Assay Drift

Azadeh¹,

Sondag²,

Wang

et al. 2019

AAPS J

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Quality controls (QCs) are the primary indices of assay performance and an important tool in assay lifecycle management. Inclusion of QCs in the testing process allows for the detection of system errors and ongoing assessment of the reliability of the assay. Changes in the performance of QCs are indicative of changes in the assay behavior caused by unintended alterations to reagents or to the operating conditions. The focus of this publication is management of QC life cycle. A consensus view of the ligand binding assay (LBA) community on the best practices for factors that are critical to QC life cycle management including QC preparation, qualification, and trending is presented here. Electronic supplementary material The online version of this article (10.1208/s12248-019-0354-6) contains supplementary material, which is available to authorized users.

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Section: Qc Performance Trendingmentioning

confidence: 99%