USP <1058> Analytical Instrument Qualification and its Impact on the Chromatography Laboratory
June 1st 2009United States Pharmacopeia (USP) general chapter 1058 on analytical instrument qualification (AIQ) has finally become official and was released in August 2008 in the first supplement to the USP XXXI.1 This column reviews AIQ and discusses the impact it will have in the regulated chromatography laboratory.
Cost Beneficial Validation of a Site-wide Chromatography Data System
September 1st 2005The implementation and validation of a new site-wide chromatography data system for a major active pharmaceutical ingredient custom manufacturer provided the opportunity to map and optimize the GMP and ISO business processes to use electronic signatures effectively. This article describes the process optimization and how it integrates with the validation activities of the system. This overall approach provides substantial business benefits from the use of electronic signatures as evidenced by the savings resulting from process improvement and by the fact that the non-GMP laboratories implemented a similar process to analyse and approve results electronically.
Chromatography Data Systems, Part III: Prospective Validation of a Chromatography Data System
May 1st 2000The first two parts of this series covered the fundamentals of a system and the specification, evaluation, and selection of a chromatography data system. Part III discusses the validation work in parallel with progress through the life cycle of the project.
Chromatography Data Systems, Part II: Specifying, Evaluating, and Selecting a System
February 1st 2000In the second installment of this series, the author looks at the first phase of the life cycle of a new chromatography system, bringing together a number of elements of the workflow and the functions as they are used in the laboratory.