How to Set Up a GLP Quality Assurance Unit
Build an inspection function whose independence is structural rather than declared.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
The quality assurance unit in a good laboratory practice facility is not a quality department in the manufacturing sense. It has a specific job: to verify that studies are conducted according to the plan and the applicable principles, and to report what it finds to management. Its value comes entirely from its independence, which is why the most damaging finding against one is that it reports to the people whose work it inspects.
- 1
Separate the unit from study conduct completely
Personnel who conduct or direct a study cannot inspect it. Where a small facility struggles with this, the answer is an external or corporately separate inspector for that study — not an internal arrangement that asks someone to inspect work they contributed to.
- 2
Maintain a copy of every study plan and a master schedule
The unit needs to know which studies exist, their status, the test item, the director, and the sponsor. A master schedule that is reconstructed for an inspection rather than maintained continuously cannot show that studies were tracked while they were running.
- 3
Inspect at intervals adequate to assure study integrity
Plan inspections against the study phases that matter — critical phases, the ones where an error would not be recoverable — rather than at an arbitrary calendar cadence. Record what was inspected, when, and what was found, including inspections that found nothing.
- 4
Report findings to management as well as to the study director
The dual reporting line is what gives the unit force. Reporting only through the director makes the escalation of a problem dependent on the person responsible for the work agreeing that it is one.
- 5
Audit the final report against the raw data
Before the report is signed, verify that it accurately reflects the raw data. This is the unit’s highest-value activity and the one most often compressed by schedule pressure, which is precisely when it is most needed.
- 6
Issue the quality assurance statement
The statement in the final report identifies the inspections performed, their dates, and the dates findings were reported to management and to the director. It is the evidence that the unit did its job, and a statement listing dates that do not correspond to a maintained record is worse than no statement at all.
- !Inspectors drawn from the same group that conducts the studies, so independence is asserted rather than structural.
- !A master schedule assembled for the inspection rather than maintained while studies ran.
- !Findings routed only through the study director, removing the escalation path.
- !The report-versus-raw-data audit compressed under schedule pressure, which is when it matters most.
How to Set Up a GLP Quality Assurance Unit: frequently asked questions
Common questions on set up a glp quality assurance unit.
How independent does the unit actually have to be?
Independent of the studies it inspects, in substance. Personnel who conducted or directed a study may not inspect it. In a facility too small to staff that internally, the workable answer is an external or corporately separate inspector for that study, not an internal arrangement that dilutes the requirement.
What is a critical phase and why plan around it?
A point in a study where an error would not be recoverable afterwards — dosing, key observations, sample collection. Inspecting these rather than at an arbitrary calendar interval is what makes the programme meaningful, because an inspection scheduled for a quiet week verifies a quiet week.
What does the quality assurance statement have to say?
Which inspections were performed and when, and when the findings were reported to management and to the study director. Those dates are checked against the unit’s own records, so a statement that cannot be reconciled to a maintained record undermines the report it is attached to.