Learn FDA GLP master schedule requirements, who maintains the schedule, required fields, date rules, and a practical pharmaceutical laboratory template.
GLP master schedule is the facility register of applicable nonclinical laboratory studies. It helps management track workload and gives the Quality Assurance Unit (QAU) a current view for planning oversight. In pharma, it may cover a 28-day toxicity study or an in vitro genotoxicity test; it is not a routine production-testing log.
For U.S. FDA-regulated work, the core requirements appear in 21 CFR 58.35(b)(1). The details matter: some fields are expressly listed in the regulation, while common spreadsheet columns such as study ID, protocol approval date, or experimental dates are useful local additions rather than a verbatim federal checklist.
Key takeaways
- FDA Part 58 requires the QAU to maintain a copy for applicable studies.
- FDA-listed fields include test article, test system, study nature, initiation date, status, sponsor, and Study Director.
- OECD GLP places schedule maintenance with facility management and gives QA access to an up-to-date copy.
- Study IDs, titles, experimental dates, and change history are useful additions, not universal Part 58 fields.
What belongs on a GLP master schedule?
Under FDA Part 58, the QAU maintains a copy of a schedule of nonclinical laboratory studies, indexed by test article. The required schedule information is more concise than many templates suggest:
| FDA-listed information | How a pharma laboratory might record it |
|---|---|
| Test article index | Compound code or controlled test-article name |
| Test system | Sprague-Dawley rat, CBA/J mouse, or CHO cell line |
| Nature of study | 28-day repeat-dose toxicity or in vitro micronucleus test |
| Date study was initiated | For FDA master-schedule purposes, see the date clarification below |
| Current study status | In life, data analysis, reporting, completed, or terminated |
| Sponsor identity | Sponsor name or a controlled code with a retrievable identity |
| Study Director | Name of the individual responsible for overall study conduct |
Add a study number and title for retrieval. Site or Principal Investigator, protocol approval date, experimental window, and report dates can also support planning, but are not all universal Part 58 schedule fields.
Which dates should the schedule show?
FDA’s GLP questions and answers clarify that, for master-schedule purposes, a study is initiated when management approves the protocol and remains listed until the Study Director signs the final report. “Date initiated” therefore does not necessarily mean first dose or first data collection. Protocol-proposed experimental dates serve a different purpose.
Example: a protocol is approved October 12; dosing begins October 20 and the last planned observation is November 17. Separate columns keep these dates clear for QA and resource planning.
Practical GLP master schedule template
The following is an illustrative row, not a completed regulatory record. Adapt status terms, date definitions, and access controls to the facility’s applicable GLP program and approved procedure.
| Study ID | Study / nature | Sponsor | Test article | Test system | Study Director | FDA initiated date | Experimental window (planning) | Status | Final report signed |
|---|---|---|---|---|---|---|---|---|---|
| GLP-26-014 | 28-day oral toxicity | SP-042* | Compound X | Sprague-Dawley rat | Dr. A. Patel | 12 Oct 2026 | 20 Oct–17 Nov 2026 | In-life | Pending |
*If a sponsor code is used, retain a controlled mapping that allows the sponsor’s identity to be retrieved for inspection. A code alone should not obscure the required sponsor identity.
Ownership, updates, and inspection readiness
FDA says the QAU maintains a copy. OECD GLP assigns maintenance to test-facility management and says QA should access an up-to-date copy. The responsible party therefore depends on the framework.
A single controlled register is a practical model, but the cited provisions do not ban department views or specify software. An Excel file or LIMS/QMS can work if it yields a complete, current schedule. The SOP should define ownership, update timing, access, correction history, sponsor-code lookup, and retention. Dated edits with reasons are prudent data-integrity controls; Part 58 does not expressly require a separate formal change-control record for every schedule edit.
- Reconcile entries with protocol approvals; review active status routinely.
- Record completion or termination through the facility’s controlled process.
- Keep study dates distinct from batch and routine QC timelines.
GLP master schedule versus a GMP production schedule
A GLP master schedule tracks regulated nonclinical studies and supports study oversight. A GMP production or QC schedule tracks activities such as tablet compression, microbiological testing, or batch release under applicable manufacturing controls. A routine assay of a commercial batch is not automatically a GLP study just because it occurs in a laboratory. See the FDA’s cGMP overview for the separate manufacturing context.
Authoritative external references
- U.S. FDA regulation: 21 CFR 58.35, Quality Assurance Unit
- FDA: 1981 Questions & Answers on GLP Regulations
- OECD Principles of Good Laboratory Practice
- OECD: Quality Assurance and GLP
Frequently asked questions
1. Is a GLP master schedule required by FDA?
Yes. Under 21 CFR 58.35(b)(1), the QAU must maintain a copy of a master schedule sheet for applicable nonclinical laboratory studies.
2. Who is responsible for maintaining the schedule?
For FDA Part 58, the QAU maintains a copy. Under OECD GLP, facility management ensures the master schedule is maintained, and QA has access to an up-to-date copy.
3. What fields are explicitly listed by FDA?
The schedule is indexed by test article and contains the test system, nature of study, date initiated, current status, sponsor identity, and Study Director’s name.
4. Does FDA require a spreadsheet or a specific template?
The cited provision specifies schedule content, not a particular software or file format. Use a controlled format that can be kept current and made available to the QAU and inspectors.
5. Is a unique study number mandatory?
It is a useful facility identifier, but it is not one of the fields expressly enumerated in 21 CFR 58.35(b)(1). Define it in the facility’s system and SOP.
6. Must the schedule list experimental start and end dates?
They are useful planning columns. FDA’s GLP Q&A says the master-schedule initiation date is management’s protocol approval date and the study completion point is the Study Director’s final-report signature date.
7. Does the QAU independently own the master schedule?
Not as a universal rule. FDA requires the QAU to maintain a copy; OECD assigns maintenance to facility management and gives QA access to an up-to-date copy.
8. Can the sponsor be shown by a code?
A controlled code can protect confidentiality in routine views, but the required sponsor identity must remain readily retrievable. Confirm the approach against applicable local requirements and the facility SOP.
9. Should terminated studies remain on the schedule?
The schedule should show current status. Record termination using the facility’s procedure and preserve the study record and status history according to applicable requirements.
10. Does the GLP schedule cover routine GMP batch testing?
Not automatically. The schedule concerns applicable nonclinical studies under GLP. Routine manufacturing and batch testing are generally governed by applicable GMP requirements.