Paul Smith | Authors

Articles

Data Integrity and USP : Part 3: Monitoring and Requalification

This is the final part of a trilogy looking at the impact of the new USP on analytical instrument qualification (AIQ) on data integrity in a regulated chromatography laboratory. This part will focus on the performance qualification (PQ) portion of the 4Qs model and, specifically, monitoring and requalification of chromatographs.

Data Integrity and USP , Part 2: OQ Supervision and Execution

This is the second of three articles looking at the impact of the new United States Pharmacopeia (USP) on analytical instrument qualification (AIQ) on data integrity in a regulated chromatography laboratory. This part focuses on how the laboratory should supervise the execution of operational qualification (OQ) protocols by a third-party service provider. The principles described also apply to in-house metrology departments.

Data Integrity and USP : Part 1 Specifications and Suppliers

This is the first of three articles looking at the impact of the new United States Pharmacopeia (USP) chapter on Analytical Instrument Qualification (AIQ) on data integrity in a regulated chromatography labora-tory. In part 1, user specifications for chromatography systems and the relationship between users and sup-pliers will be discussed.