Laboratories · GLP Compliance
GLP Compliance Consulting for Nonclinical Laboratories
The short answer
Good Laboratory Practice under 21 CFR Part 58 governs nonclinical safety studies intended to support applications. Compliance rests on three structures: an independent quality assurance unit, a study director with genuine control of the study, and raw data that can reconstruct it.
Why this matters
- A GLP study that cannot be reconstructed may not be usable for its intended purpose, regardless of the result.
- The QAU's independence is a structural requirement; laboratories often staff it in a way that compromises that independence without realising.
- Contract laboratories carry the sponsor's risk, and sponsor oversight is frequently limited to reading the final report.
Applicable regulations and standards
- 21 CFR Part 58
- Good Laboratory Practice for nonclinical laboratory studies.
- 58.31 / 58.33 / 58.35
- Management, study director and quality assurance unit responsibilities.
- 58.130 / 58.190
- Conduct of the study, raw data, and storage and retrieval of records and specimens.
- OECD GLP Principles
- Applicable where studies support non-US submissions.
What our consultants actually do
- Assess the GLP quality system against Part 58 and rebuild the SOP architecture where it does not match practice
- Establish or strengthen the QAU: inspection schedules, study-based and process-based inspections, reporting lines and records
- Clarify study director responsibilities and the documentation that demonstrates study control
- Improve protocol, amendment and deviation practices so the final report reflects what happened
- Assess raw data practices, specimen handling and archive controls, including electronic raw data
- Support sponsors in qualifying and overseeing contract nonclinical laboratories
Across the product lifecycle
01 / DEVELOP
Study design and protocol quality before the first animal or sample.
02 / SCALE
Capacity, facility and personnel qualification for study load.
03 / TRANSFER
Sponsor oversight when studies are placed with contract laboratories.
04 / VALIDATE
Equipment calibration, maintenance and computerized system controls.
05 / MANUFACTURE
Test article characterization, accountability and dose formulation analysis.
06 / MAINTAIN
Archive integrity, records retention and QAU trend reporting.
Problems we are usually called about
- QAU reporting to the same manager who is accountable for study delivery
- Study director signing reports for studies conducted at multiple sites with no site management records
- Test article characterization and stability data missing from the study file
- Protocol deviations recorded in the study file but omitted from the final report
- Electronic raw data stored on instrument workstations outside the archive
Typical deliverables
- Part 58 gap assessment with prioritized findings
- QAU program design: inspection schedule, templates and reporting
- SOP architecture and revision plan
- Archive and raw data control assessment
- Contract laboratory qualification and oversight framework
Frequently asked
- Which studies must be conducted under GLP?
- Nonclinical laboratory safety studies intended to support applications for research or marketing permits. Efficacy, exploratory and method development work generally falls outside Part 58, though a written policy defining the boundary is expected.
- Can the QAU report to laboratory management?
- The QAU must be entirely separate from and independent of the personnel engaged in the conduct of the study. A reporting line that creates pressure over study outcomes undermines that independence even where the organisation chart looks acceptable.
- Do you support laboratories preparing for BIMO-type review of nonclinical data?
- We support the GLP quality system and study documentation that such a review would examine. For inspection-specific readiness services, we route clients to FDAInspections.com.
References
More for laboratories
GLP and GMP laboratory compliance, data integrity and analytical operations.
- Data IntegrityLaboratory data integrity is a question of whether every reported result can be reconstructed from complete, attributable, contemporaneous records.
- GMP Laboratory ComplianceA GMP quality control laboratory is judged on laboratory controls: qualified instruments, validated methods, controlled reference standards, complete records and investigations that reach a conclusion.
- Method ValidationMethod validation demonstrates that an analytical procedure is suitable for its intended purpose.
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