The fundamental requirements of current good laboratory practice are that:
- The laboratory has adequate facilities, accommodation, trained personal and approved written procedures to perform the study(ies) in a timely and compliant manner
- The study is performed according to a pre-approved study plan, and any deviations from the plan are documented and their impact on the validity of the studies conclusions is evaluated and approved
- A specific individual, who is qualified by an appropriate combination of education, training and experience, is appointed to oversee the conduct of the study
- All staff should be demonstrably competent, and qualified by a suitable combination of education, training and experience to perform their assigned roles; and also be free of any undue management, financial, commercial or other pressures that may compromise the integrity of their judgement and the proper discharge of the duties
- The laboratory maintains a quality assurance program, that is managed by staff that are free of undue influence that may affect their judgement, and the proper discharge of their duties. The person in charge of the quality assurance program shall have direct access to the highest levels of management at which laboratory policy, and resourcing decisions are made
- All laboratory instruments used in studies are demonstrably suitable for their purpose
- All analytical testing methods are suitably validated
- All instruments used for testing are suitable for their purpose, perform to appropriate performance specifications, are maintained and calibrated at regular intervals according to a written schedule. Any instrument not performing to established specifications shall not be used
- The laboratory takes appropriate precautions to prevent contamination and mix-ups of test and reference items
- All analytical testing is documented and demonstrate that testing was actually carried out according to written approved procedures
- Any deviations are fully documented and investigated
