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ing can be equally applied to all studies in order to maintain the equipment in proper regulatory com- pliance. l Appropriate equipment is maintained for in vitro and ex vivo study procedures. l A Department of Maintenance & Metrology is recommended. They inspect, clean and maintain equipment. These activities are documented in equipment SOPs. l Verification and calibration may be conducted in-house by study personnel or maintenance and metrology personnel, or these tasks may be per- formed by equipment vendors or specialised con- tractors as necessary. l Where applicable all equipment use is docu- mented in instrument logbooks. Records of equip- ment inspection, maintenance, testing, calibration and standardisation are archived and retained.
Test and control articles l Full characterisation of test and control articles is not required for non-GLP studies. l Test and control articles are assigned internal tracking numbers. Information on test article receipt and distribution are stored in a central loca- tion and are archived as facility records. Copies are maintained in the study records. l Retention of test and control article samples is not required, as in-life study segments (dosing to observation) typically last less than four weeks. Test and control articles remaining after the study’s end should be returned or destroyed, as per the sponsor’s request. l Test dosing solutions are analysed for concentra- tion and stability for GLP-compliant studies; this analysis is not required for non-GLP studies. A sponsor may provide information on the stability of test solutions; however, if the stability is unknown or has not been characterised, a fresh solution is prepared daily.
Protocol and study conduct l Contract studies are conducted according to the applicable GLP regulations and the protocol. l Preprinted forms with selected data may be used, but these must be verified prior to the con- duct of any study. The same documentation requirements are applied to both GLP-compliant and non-GLP studies.
Reporting l A final report summarising study methods and results, including applicable components listed in the GLP regulations and study protocol must be prepared.
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l In a GLP-compliant study report, a compliance statement stipulating the regulations followed in the conduct of the study and any GLP deviations that occurred is included. Protocol deviations are reported for both GLP-compliant and non-GLP studies. l Corrections or changes to a final report for both GLP compliant and non-GLP studies are only made through amendment as described in the GLP regulations, with prior approval from the sponsor. l Alternatives to preparing a complete final report for a non-GLP study can be offered, such as a data summary or other simplified version, according to the sponsor’s requirements.
Records storage, retrieval and retention l All study records must be maintained in a facil- ity archive. Records are indexed and stored either at the test facility or transferred to an offsite com- mercial archive facility. l Records from GLP-compliant studies should be stored in fire-resistant cabinets within a restricted access archive room. Access to the archives is con- trolled, and all access to the archive room and archived records is documented and logged. l Records from non-GLP studies may be stored in the same archive room with controlled access (as GLP studies), but they may not necessarily be stored in fire-resistant cabinets. l GLP studies require record retention from the time the sponsor applies for a permit or submits required documents to the FDA. Sponsors may request a specific retention period for study records at the test facility or may request that records be transferred to them after a designated period of time. Otherwise, standard record retention policies based on the specific SOP or default time periods are followed.
Electronic record and electronic signatures l Instruments, software and networked environ- ments generate electronic records and signatures. Relevant FDA 21 CFR Part 11 regulations are applied differently in a GLP-compliant versus a non-GLP study. l Computerised systems used in GLP-compliant studies must meet all Part 11 requirements includ- ing validation and electronic signatures, whereas computerised systems used in non-GLP studies may not be validated or include electronic signatures. l A computerised system master list identifying all systems and their validation status must be main- tained. Individual system SOPs cover the use of electronic signatures and the maintenance of elec- tronic records.
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