The quality assurance (QA) unit consists of four full time GLP members and members of the QAU attend SQA meetings every year. The QA manager has been RQAP-GLP certified since 2009. A sign at the entrance to the preclinical building identifies it as a GLP area and instructs to comply with all SOPs. Personal protective equipment standards are taken very seriously. All equipment for GLP use is clearly labeled as GLP. Equipment logbooks are maintained near each piece of equipment and all equipment records from previous years had been archived at the time of inspection. Pipettes are calibrated quarterly. Instruments in use for GLP formulation analysis are all indicated the last date of maintenance and calibration and show the next dates due - labels are firmly secured to the equipment and instruments. In the event of power failure, power is switched to generators within 10 minutes. Temperature and humidity in the test article storage room are monitored by a biannually calibrated thermo hygrometer. Sample storage environmental monitoring performed using SENSATRONICS.
The Medicilon archive meets regulatory expectations for security. The room is locked, it is accessible only by the archivist and entry to the room is tracked with a sign-in sheet. The Archive is protected by a water sprinkler system and archived materials are protected from water damage in plastic bags. Electronic archived materials are stored on CD/DVD in metal boxes locked in a separate cabinet, but within the same room. Pest control material is dispersed among the cabinets. Annual GLP refresher training is performed; training records are maintained in the group leader’s cabinets. Deviations from the SOPs and protocol in the reviewed method validation were properly documented and the impact appropriately addressed by the study director. QC review was clearly documented throughout the raw data. The QA statement indicated several inspections were performed and all equipment use was tracked appropriately.
QC review was clearly documented throughout the raw data. The QA statement indicated several inspections were performed and all equipment use was tracked appropriately.
From SK Life Science R&D Park
The results of an intensive three days audit onsite of GLP systems and procedures, as well as site and personnel, operating systems and procedures and raw data and final report from one non-GLP study lead to the conclusion that Medicilon is qualified and capable of conducting non-clinical GLP studies in compliance with the US FDA GLP. The personnel who participated the audit were knowledgeable and professional. The results of an intensive three day audit as well as faci