Focus on Quality: USP <1058> and the GAMP Guide on Laboratory Computerized Systems - Is Integration Possible?

摘要

The United States Pharmacopeia general chapter on analytical instrument qualification (USP <1058>) and the ISPE's Good Automated Manufacturing Practice (GAMP) Good Practice Guide on laboratory computerized systems are the two main sources of guidance for qualifying analytical instruments and validating computerized systems used in the laboratory. This column explains the discrepancies between the two documents as well as changes now being made to both in an attempt to enable an integrated approach to qualification and validation of laboratory instruments and systems.