Business
These responsibilities are outlined in SOPs. The
study director, facility management and archivist roles are equally applied to non-GLP studies.
l Any corrective actions taken to protocols or SOPs and any GLP deviations must be documented. lOne study director is responsible for the conduct of each GLP-compliant or non-GLP study and acts as the study’s single point of control. l The quality assurance unit (QAU) monitors GLP studies, reporting to management and the study director. The QAU does not monitor all non-GLP studies or records; however, the QAU does perform facility and process-based inspections of all facility operations to ensure that no deviations were made without proper documentation and authorisation. The QAU also maintains copies of all GLP-compli- ant and non-GLP audited protocols and a master schedule sheet (MSS) of all GLP-compliant and non-GLP audited studies conducted at the facility.
Facilities l As per GLP regulations, adequate facilities must be provided for each study. l Adequate, procedure-specific laboratory areas contain: m Test article and control article receipt and storage
m Test article and control article storage m Solution preparation m Microsome preparation
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m LC-MS-MS analysis m Sterile and aseptic procedures m Biohazard procedures
l On-site facility archives should be maintained, but specimen archives are not required. At the close of a study, specimens may be shipped to the sponsor or another, designated storage location. Or, they may be disposed of at the sponsor’s request. These procedures are the same for both GLP-compliant and non-GLP studies.
Standard operating procedures l SOPs covering laboratory operations as listed in the GLP regulations are maintained. These proce- dures cover both in vitro and ex vivo studies. l Additional SOPs cover experimental methods and procedures appropriate for specific studies (ie drug metabolism and drug interaction studies). l Management must approve all new and revised SOPs. l An archive is maintained for all historical ver- sions of SOPs. lHard copies are available in laboratories and elec- tronic SOPs are available at all workstations. With a few exceptions, the same SOPs support the conduct of both GLP-compliant and non-GLP studies.
Equipment l Study personnel may use the same laboratories and equipment for all contracted studies. Thus maintenance, calibration, testing and record keep-
Drug Discovery World Winter 2018/19
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