Identifying and Mitigating Errors in Screening for Organic Extractables and Leachables: Part 3—Considering Errors of Implementation and the Use of a Database to Judge and Promote Good Science and Efficient Practices

摘要

Substances leached from pharmaceutical manufacturing systems, packages, and/or medical devices can be administered to a patient during a clinical therapy and can adversely affect the therapy and/or patient safety. Thus, extracts or drug products are chromatographically screened to discover, identify, and quantify these unspecified foreign impurities. Although screening methods have achieved a high degree of technical and practical sophistication, they are not without issues in terms of accomplishing these three functions. In this third (and last) part of the series, errors of implementation are addressed. An error of implementation occurs when a capable method and/or a proper data processing procedure is implemented in such a way that the intrinsic capabilities of either the method or the processing procedure (or both) are compromised. System suitability assessment establishes that a method, as executed at the time of use, has been properly set up and implemented, thus revealing errors of implementation. System suitability data, captured in a database, can be processed to establish trends in system performance, where trends in declining performance can establish a system's useful operating lifetime, serve as an early warning of imminent system failure, and/or act as a trigger for system maintenance. Additionally, this manuscript considers how the existence, size, and use of a chromatographic database provides a measure of a testing laboratory's level of “good science”. Lastly, the manuscript considers the database as an enabler of advances in information management and impact assessment.