Learn which GLP Documentation to maintain, how to correct entries, and how to protect paper and electronic data in pharmaceutical studies.
In this article, GDP means Good Documentation Practice—not Good Distribution Practice. Strong GLP documentation lets reviewers reconstruct how a nonclinical study was planned, performed, analyzed, and reported. It helps protect data integrity and supports regulatory review.
Good documentation practices are not a separate universal regulation created only for GLP. Rather, GLP and cGMP rules contain specific requirements for records, while GDP describes practical habits for creating, correcting, reviewing, and retaining trustworthy records.
Why documentation matters in GLP
Good Laboratory Practice applies to the organization and conduct of applicable nonclinical studies. In the United States, FDA’s GLP requirements are in 21 CFR Part 58. They cover study protocols, personnel, standard operating procedures, raw data, quality assurance, final reports, and archives. OECD GLP principles similarly address how nonclinical studies are planned, performed, monitored, recorded, reported, and retained.
For example, a GLP toxicology study of a drug candidate may include animal observations, clinical signs, dose preparation records, specimen results, and pathology findings. The documentation should make it possible to trace each result to the study, test system, method, date, and responsible personnel.
Core GLP documentation practices
A useful documentation system makes records:
- Legible: entries can be read and understood by another qualified reviewer.
- Attributable: the person who performed or recorded the activity is identifiable.
- Contemporaneous: data are recorded when the work occurs, rather than reconstructed later.
- Accurate and complete: records reflect what was performed, including unexpected results or deviations.
- Traceable: each record connects to its study, procedure, equipment, sample, and relevant personnel.
- Retrievable: records are organized, protected, and available for review throughout their retention period.
For manually recorded data in an FDA GLP study, 21 CFR 58.130(e) requires direct, prompt, and legible recording in ink, with the entry dated and signed or initialed. Corrections must not obscure the original entry and must include the reason, date, and identification of the person making the change. Follow the applicable procedures for electronic data.
Essential GLP records
| Record type | What it helps demonstrate | Pharmaceutical example |
|---|---|---|
| Approved protocol and amendments | Study objectives and planned methods | Dose groups and sampling schedule for a toxicity study |
| SOPs and revision history | Procedures were controlled and current | SOP for specimen collection or HPLC analysis |
| Raw data and supporting records | Results can be reconstructed and evaluated | Instrument output, calculations, observations, and sample identifiers |
| Test-article records | Identity and handling of the material are traceable | Receipt, storage, preparation, and characterization of an API |
| Equipment records | Equipment status was suitable for its use | Calibration and maintenance records for an analytical balance |
| Deviations and corrective actions | Unexpected events and their impact were assessed | Missed sampling time documented, evaluated, and reported |
| QA inspection records | Required study oversight was performed | Inspection record identifying study phase, findings, and follow-up |
| Final report and archive records | Results and source materials are preserved | Signed study report linked to retained raw data and specimens |
FDA GLP rules require written study protocols, SOPs, records of study conduct, final reports, and archives. Records and specimens must be stored so they can be retrieved and protected from deterioration. Retention periods depend on applicable requirements and the type of study; do not assume one timeline applies to every record.
Practical example: recording an unexpected result
Suppose a laboratory analyst finds an unexpected result while testing a specimen from a GLP study. The analyst should preserve the original observation, identify the specimen and method, record the date and time as required by procedure, and notify the appropriate study personnel. Any investigation, repeat analysis, or protocol deviation should be documented and reviewed; the original result should not be silently replaced.
This supports reconstruction of the study and allows the study director to evaluate whether the event affects the interpretation or reporting of results.
QA oversight and electronic records
In FDA GLP studies, the quality assurance unit monitors study activities and maintains records of its inspections. Its role is to check compliance and report findings through the applicable processes; it does not replace the study director’s responsibility for the study’s technical conduct.
Electronic systems can improve retrieval and review, but they do not automatically prevent data errors. OECD guidance recommends a risk-based life-cycle approach to the validation and operation of computerized systems in GLP environments, with attention to data integrity. Depending on the system and applicable rules, controls may include access permissions, backups, audit trails, and review procedures.
ALCOA and ALCOA+ are commonly used frameworks for discussing data integrity. They complement—not replace—specific GLP, cGMP, and electronic-record requirements. FDA’s drug cGMP data-integrity guidance emphasizes that data should be reliable and accurate.
How GLP records differ from cGMP records
GLP records support the reconstruction of a nonclinical study. In a pharmaceutical manufacturing setting, cGMP records instead document production, control, testing, and decisions about a batch. For example, FDA’s Part 211 requirements address batch production and control records and laboratory records for testing against specifications.
The same laboratory may conduct GLP study work and GMP quality-control testing, but the applicable procedures and records depend on the activity. A GLP study file does not replace a GMP batch record, and a batch record does not establish that a nonclinical study complied with GLP.
Key takeaways
- GLP documentation should allow a reviewer to reconstruct the study.
- Maintain controlled protocols, SOPs, raw data, deviation records, QA records, final reports, and archives as applicable.
- Record data promptly; correct entries transparently without obscuring the original.
- Electronic records need suitable controls based on the system and applicable requirements.
- Apply the recordkeeping rules relevant to the activity: GLP for applicable studies, cGMP for regulated manufacturing and quality-control operations.
Frequently asked questions
1. What is GLP documentation?
It is the controlled record of how an applicable nonclinical study was planned, performed, monitored, analyzed, and reported.
2. Is Good Documentation Practice a separate GLP regulation?
GDP is a general practice framework. Specific recordkeeping duties come from applicable GLP, cGMP, and electronic-record rules.
3. What are essential records in a GLP study?
Common records include the protocol, SOPs, raw data, study-related records, QA inspection records, final report, and archived materials.
4. How should a handwritten GLP entry be corrected?
Under FDA’s relevant GLP rule, preserve the original entry and document the correction’s reason, date, and responsible person’s identity.
5. Can GLP data be recorded electronically?
Yes, when electronic systems and records meet applicable requirements and preserve data integrity and retrievability.
6. Are audit trails always required for GLP electronic records?
Requirements depend on the applicable rules and system. OECD guidance discusses audit-trail and data-integrity controls for computerized GLP systems.
7. Does ALCOA+ replace GLP documentation requirements?
No. It is a useful data-integrity framework, but it does not replace applicable regulations or approved procedures.
8. Who is responsible for GLP documentation?
Study personnel record their work; the study director oversees the study; QA performs the independent oversight functions required by the applicable GLP framework.
9. Is GLP documentation the same as GMP documentation?
No. GLP records support nonclinical study reconstruction. GMP records document manufacturing, testing, and product-quality decisions.
10. Is there one GLP record-retention period for every document?
No. Retention depends on the applicable regulation, record type, and study context. FDA GLP rules specify retention provisions and should be checked for the specific study.