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Personnel
Personnel conducting or supporting GLP studies must document that they are qualified to perform assigned study duties through education, experience, training, or a combination thereof. Study personnel conducting or supporting GLP studies:
- Must have GLP training at least biennially.
- Must maintain current records of training, education, and job description.
- Must follow health and sanitation procedures to avoid contamination of test systems and test and control articles. Departments or units conducting GLP studies must have management approved standard operating procedures defining health and sanitation measures to be followed.
- Must wear clothing suitable for the tasks to be performed and to avoid contamination of test systems and test and control articles.
- Must report to their supervisor any illness or medical condition that may adversely affect the test article, control article, test system, or performance of study activities and must be excluded from participating in the study until the condition is resolved.