SOP: GLP Quality Assurance Unit (QAU) Program

This is a ready-to-use SOP for operating a GLP Quality Assurance Unit (QAU), the independent function 21 CFR 58.35 requires at every test facility. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, and route it through your normal document control, review, and approval. A worked filled specimen follows. Verify each cited regulation against the current source before you rely on it.

Document control header

1. Purpose

This procedure defines how the Quality Assurance Unit (QAU) at <<FILL: COMPANY / FACILITY NAME>> independently verifies that GLP nonclinical laboratory studies are conducted, documented, and reported in accordance with the approved protocol, applicable SOPs, and 21 CFR Part 58, so that senior management and study directors receive an independent assessment of study integrity.

2. Scope

This procedure applies to every nonclinical laboratory study conducted under GLP at the facility, whether conducted entirely on site or with delegated phases at another test site. It covers the master schedule, protocol and SOP recordkeeping, phase inspections, final report audit, and the QA statement. It does not cover the study director’s technical conduct of the study, which is governed by the study-specific protocol and <<FILL: SOP-ID for study conduct>>.

3. Responsibilities

4. Definitions

• Master schedule sheet: a facility-wide index of all GLP studies, indicating test article, test system, study director, and study status, updated continuously.
• Phase inspection: a QAU inspection of a specific, defined stage of a study (for example the first day of dosing, terminal necropsy) performed while that phase is occurring.
• Process-based inspection: a QAU inspection of a recurring process (for example, dosing technique across all active studies in a given week) rather than a study-specific phase, permitted under OECD GLP where it provides adequate coverage of every study.
• QA statement: the signed, dated attestation in the final report listing the dates QAU inspections occurred and the dates findings were reported to the study director and management.

5. Procedure

5.1 Maintain the master schedule and controlled document library

1. Add every new GLP study to the master schedule sheet before or at study start, with test article, test system, study director, and planned start/end dates.
2. Update study status (in-life, in report, completed, terminated) as it changes.
3. Maintain current copies of all approved protocols and amendments, and current copies of all SOPs referenced by active studies.

5.2 Inspect the protocol before study start

1. Review the signed protocol against the 58.120 required-element checklist before in-life work begins.
2. Confirm the study appears on the master schedule and that referenced SOPs are current and available to study personnel.
3. Document the protocol review with a date; this date is one of the entries the QA statement will later cite.

5.3 Perform phase inspections during the study

1. Schedule inspections of the phases where errors are most consequential and least recoverable: first day of dosing, dose preparation and verification, key clinical observation points, and terminal procedures/necropsy, at minimum.
2. Observe the activity live where feasible, and document what was observed against what the protocol and SOP specify.
3. Where the facility uses process-based inspection for high-volume, routine activities, confirm and document that every active study still receives adequate coverage, consistent with OECD GLP guidance.
4. Report any finding to the study director and to management, in writing, the same week, and log the date reported.

5.4 Audit the draft final report

1. Trace a risk-weighted sample of reported values, prioritizing the endpoints that drive the study’s conclusion, back to raw data.
2. Confirm the deviation log is fully and accurately reflected in the report’s description of circumstances that may have affected the data.
3. Confirm the report’s stated methods and procedures match what was actually approved and, where changed, that every change has a corresponding signed amendment.
4. Return findings to the study director for correction before the report is finalized.

5.5 Prepare and sign the QA statement

1. List the dates of the protocol review, each phase inspection, the data audit, and the report audit.
2. List the dates findings from each were reported to the study director and to management.
3. Sign and date the statement; it becomes part of the final report per 58.185.

5.6 Maintain independence and manage FDA/OECD access to QAU records

1. QAU personnel do not perform study-conduct duties on any study they inspect, and do not report to the study director for that study.
2. Per 21 CFR 58.35(c), the QAU’s master schedule, written procedures, and inspection dates are available for review; detailed inspection findings are generally not subject to routine copying. Confirm your current understanding of this provision against the regulation before an inspection.
3. Log every request for QAU records during an inspection and the response given.

6. Acceptance criteria

• Every active GLP study appears on the master schedule with current status.
• Every study has a documented protocol review before start, at least the phase inspections listed in 5.3, a data audit, and a report audit before finalization.
• Every QAU finding was reported to both the study director and management, in writing, with a dated record.
• The final report’s QA statement lists every inspection date and every reporting date, and is signed before or concurrent with the study director’s report signature.
• No QAU member performed study-conduct duties on a study they inspected.

7. Records generated

• Master schedule sheet (continuously maintained).
• Phase inspection records, one per inspection.
• Report audit findings.
• Signed QA statement (part of the final report).

8. References

21 CFR 58.35, Quality Assurance Unit. 21 CFR 58.120, Protocol; 21 CFR 58.185, Final report. OECD Principles of Good Laboratory Practice, and OECD consensus documents on QA program practices (process-based inspection).

Confirm the current version of each reference before issue.

9. Revision history

10. Approvals

Filled specimen: phase inspection record

Common inspection findings this SOP prevents

• No master schedule, or one that is not current, so an inspector cannot confirm what studies exist or their status.
• Phase inspections that exist on paper as a checkbox with no evidence the activity was actually observed.
• QAU findings reported only to the study director, never documented as reported to management, or vice versa.
• A report audit that never happened, discovered when a reported number does not trace to raw data.
• A QAU member who also performed hands-on study tasks on the same study.

How to adapt this SOP

1. Set your document number, owner, and effective date in the header.
2. Adjust the phase-inspection list in 5.3 to the study types your facility actually runs (add imaging, toxicokinetic sampling, or other phases specific to your programs).
3. If your facility uses process-based inspection, document the coverage-adequacy rationale explicitly, per OECD guidance.
4. Point section 2’s cross-reference to your real study-conduct SOP.
5. Confirm every regulation in section 8 against the current published version before issue.