![]() Current SOPs must be readily available in work areas and accessible to testing personnel. The laboratory must write SOPs for all laboratory activities to ensure the consistency, quality, and integrity of the generated data. Standard operating procedures (SOPs) are critical for maintaining consistent test performance. Internal preventative maintenance activities and vendor-provided maintenance and repair for laboratory equipment are paramount in providing accurate and reliable results. Proper maintenance of all laboratory equipment is necessary for assays to function within the manufacturer’s specifications. Systems are required to drive organizational structure, training, and ongoing competency assessment to ensure appropriate accountability and communication during studies. Learn more about each of the GCLP core elements below.Īppropriately trained and well-organized laboratory staff are key to the successful operation of a research facility. GCLP core elements include organization and personnel, laboratory equipment, testing facility operations, quality control program, verification of performance specifications, records and reports, physical facilities, specimen transport and management, personnel safety, laboratory information systems, and quality management.Īs a result of this core infrastructure, labs produce clinical trial data in an environment conducive to study reconstruction, enable prioritization between candidate product regimens, and guide rational decision making for moving products forward into advanced clinical trials.
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