SOPREFERENCE OUTLINE

GLP Quality Assurance Unit Charter

Charter for an inspection function whose independence is structural rather than declared: four independence tests with evidence, a master schedule maintained while studies run, an inspection programme stating what makes each interval adequate, escalation to management as well as the study director, and a final-report audit against raw data protected in the schedule. Maps to 21 CFR Part 58 and the OECD GLP Principles.

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
21 CFR Part 58OECD GLP Principles
DOCUMENT TYPE
SOP
LAST UPDATED
August 2026
PURPOSE

This unit is not a quality department in the manufacturing sense. Its job is to verify that studies are run according to the plan and the applicable principles, and to report what it finds to management. Its entire value comes from independence, and independence that is declared rather than built into reporting lines fails the first time a finding is inconvenient.

What's Inside

✓Four structural independence tests, each answered with evidence rather than an assertion of impartiality
✓Master schedule of studies maintained while they run, not assembled when an inspector asks
✓Inspection programme stating what makes each interval adequate for the study type being inspected
✓Facility and process-based inspections covering activities that span studies rather than sitting inside one
✓Reporting and escalation routes by finding type, including the route that bypasses the study director
✓Final report audit against raw data, with the audit dates the statement will eventually carry
✓Quality assurance statement wording and the records retained to support each assertion inside it

How to Use It

1Make independence structural rather than declared; inspectors drawn from the studying group make every inspection contestable whatever the individuals actually do.
2Maintain the master schedule continuously — a monitoring authority asks for it first, and one assembled retrospectively is visible as one.
3State the basis for each inspection interval; a fixed interval applied to every study type is a programme nobody has thought about.
4Keep a management reporting route; findings routed only through the study director leave the unit dependent on the person being inspected.
5Protect the report-versus-raw-data audit in the schedule; it is compressed first under deadline pressure, which is when it matters most.
6Retain the inspection records supporting your statement, and decide now who may see them and on what terms.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Purpose and Structural Independence
2Master Schedule
3Inspection Programme
4Reporting and Escalation
5Final Report Audit and Statement
REGULATORY CONTEXT

21 CFR Part 58 and the OECD Principles of Good Laboratory Practice both require a quality assurance function independent of study conduct, maintaining a master schedule, inspecting studies and facilities, auditing the final report and issuing a statement. Neither prescribes your reporting lines, your inspection intervals, or how you demonstrate that independence survives contact with a contested finding — those are your organisation’s to design and defend. The charter structure and the four independence tests are SPEQ practitioner synthesis.

MAPPED STANDARDS
21 CFR Part 58OECD GLP Principles
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