The following key points are discussed in this article:
- The US Food and Drug Administration relies on documented adherence to good laboratory practice (GLP) requirements by nonclinical laboratories in judging the acceptability of safety data submitted to the agency
- The quality assurance unit (QAU) is designed to assure test facility management of compliance with the principles of GLP
- 21 CFR Part 58.35 requires that the QAU conduct audits of nonclinical laboratory studies to assure study integrity and to assure that the study is being conducted in compliance with the approved protocol and applicable standard operating procedures
- The QAU must maintain records of each periodic inspection
- The QAU must be entirely separate from and independent of the personnel engaged in the direction and conduct of the study it monitors
- A QAU inspection or audit should be viewed as a methodical evaluation of a nonclinical study to determine if a study is being performed according to GLP principles
- There are four types of GLP audits: study-specific audits, facility audits, process-based audits, and supplier audits
- All audits have common elements involving audit preparation, conducting the audit, and preparing the audit final report
- There are also specific considerations for study audits, facility audits, process audits, and supplier audits involving audit preparation
- A specific supplier audit close-out meeting should be conducted with management
- GLP compliance monitoring is an essential step in assuring the integrity of data generated in support of regulatory submissions.
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