1.7.2 Essential Elements of a GLP System

Test facility organisation: Standard Operating Procedures govern all operations, and a Quality Assurance unit operates independently of the...

• Test facility organisation: Standard Operating Procedures govern all operations, and a Quality Assurance unit operates independently of the study-conduct team to audit compliance.
• Personnel: Staff must be appropriately trained, and a designated Study Director bears overall responsibility for the scientific and technical integrity of the entire study.
• Equipment: All instruments must be calibrated and maintained on a documented schedule, with records of use and service history retained.
• Test and reference substances: The identity, purity, stability, and homogeneity of every test article must be characterised and documented before use.
• Standard Operating Procedures (SOPs): Written, formally approved procedures must be available at the workstation where each procedure is performed.
• Study plan / protocol: A protocol must be approved before the study begins, and any subsequent amendments must be documented and justified.
• Raw data: All original observations must be recorded, and where computerised systems are used, an audit trail compliant with 21 CFR Part 11 must be maintained.
• Final report: The completed study report must be signed by the Study Director and archived, together with all raw data, typically for a minimum of ten years.

Why this matters academically

Even outside a formal GLP environment, adopting these habits — a written protocol, calibrated instruments, complete raw-data records, and a single accountable investigator — measurably improves the reproducibility of dissertation and publication-track research and pre-empts many of the data-integrity criticisms discussed in Phase 7.