Some TF activities may be performed by external suppliers (e.g. IT services, eArchive, metrology, computer system validation). What are the responsibilities of TFs with regard to these types of suppliers when these suppliers are not GLP certified (i.e. the suppliers are not included in a national GLP compliance monitoring programme)?

Test facility management has overall responsibility to ensure that the facilities, equipment, personnel and procedures are in place to achieve and maintain the validated status of computerised systems in order to establish “GLP compliant” study results. This includes the responsibility for internally as well as externally provided services (e.g. third parties, vendors, internal IT departments, service providers including hosting service providers). Depending on the provided services, a supplier’s facility need not be part of a GLP compliance monitoring program or conform to GLP regulations, but it must have a documented quality system verified as acceptable by test facility management with input from its quality assurance unit.