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GAP ASSESSMENT

Laboratory Controls

1. Are written procedures in place to define the lifecycle management of subcontractors, including their selection, qualification, and on-going performance monitoring?
2. Are the instruments in the laboratory appropriately validated and calibrated?
3. Are the gowning and personnel protective equipment procedures used in the laboratory adequate?
4. Do the cleaning procedures for reusable glassware include validation for detergents and disinfectant?
5. Is hazardous or controlled chemical waste disposed of in accordance with local environmental and regulatory codes?
6. Is there a system in place for the control and inspection of reference samples as well as retain/reserve samples?
7. Are written procedures established for the receipt, handling, storage, and discarding of test samples in laboratory areas?
8. Are written procedures established for the control and management of laboratory materials including consumables, reagents, standards, and media?
9. Are written procedures established for routine laboratory activities including handling of glassware and other laboratory materials, personnel training requirements, control of the testing environment, and handling/control of analytical methods and documentation?
10. Are written procedures established for test performance, including analytical test methods?
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