PLANREFERENCE OUTLINE

GLP Study Plan

Nonclinical GLP study plan defining objective, test system, test/reference items, Study Director and QA responsibilities, procedures, and archiving. Maps to OECD GLP and 21 CFR Part 58.

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
OECD Principles of GLP21 CFR Part 58
DOCUMENT TYPE
Plan
LAST UPDATED
January 2025
PURPOSE

The controlling document for a nonclinical safety study — objective, design, test system, responsibilities, and schedule — approved before the experimental start date. Under GLP, the study plan is not a description of intent that can drift; it is the document against which the study is conducted and audited, and every departure from it must be recorded as an amendment or a deviation.

What's Inside

✓Study identification, objective, and the regulatory purpose the study is intended to support
✓Test system, including species, strain, source, number, and the justification for the choice
✓Test and reference item identification, characterisation, and stability and homogeneity arrangements
✓Study Director designation and the responsibilities of all study personnel
✓Quality assurance programme and the planned inspection points
✓Experimental design and procedures, with the schedule and the proposed experimental start and completion dates
✓Records, data capture, specimen retention, and archiving arrangements, plus the approval block

How to Use It

1Define the objective against the regulatory purpose, so the design can be judged fit for the submission it supports
2Justify the test system rather than stating it; the justification is what a reviewer examines first
3Name the Study Director explicitly, and record the date of their approval as the reference point for the study plan
4Set the quality assurance inspection points in the plan so they are scheduled rather than opportunistic
5Detail procedures and sequence to the level a different qualified analyst could follow without interpretation
6Approve before the experimental start date, and handle every later change as a documented amendment or deviation
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
1Study Identification and Objective
2Test System and Test / Reference Items
3Study Director and Personnel Responsibilities
4QA Program and Inspections
5Experimental Design and Procedures
6Schedule and Key Dates
7Records, Data, and Archiving
8Approvals
REGULATORY CONTEXT

The OECD Principles of Good Laboratory Practice require a written study plan approved by the Study Director before the experimental start date, with amendments and deviations documented. In the United States, 21 CFR Part 58 requires an approved protocol, a designated Study Director with overall responsibility, and an independent quality assurance unit. Neither prescribes the study design for a given endpoint; the design and its justification are the sponsor's and the Study Director's determination, recorded here.

MAPPED STANDARDS
OECD Principles of GLP21 CFR Part 58
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