Good Laboratory Practice Principles

Good Laboratory Practice, or GLP, is a quality framework for the planning, performance, monitoring, recording, reporting, and archiving of certain nonclinical studies.

Core elements

GLP systems typically address:

• organizational responsibility
• study director authority
• quality assurance oversight
• approved study plans
• standard operating procedures
• equipment and facility control
• test and reference item control
• raw data
• final reports
• archives

Study plan

The study plan defines objectives, methods, responsibilities, test systems, and reporting expectations before work begins.

Raw data

Observations should be recorded directly, promptly, and traceably. Corrections should preserve the original entry.

Quality assurance unit

The quality assurance function independently inspects studies, facilities, and procedures and reports findings to management and the study director.

Frequently asked questions

Is every research laboratory a GLP laboratory?

No. GLP status depends on the applicable framework and study type.

Does GLP guarantee scientific validity?

It strengthens traceability and control but does not replace sound scientific design.

Is GLP the same as GMP?

No. GLP applies to certain nonclinical studies; GMP applies to manufacturing quality.

Why archive records?

Archiving preserves reconstructability and regulatory traceability.

Key takeaways

GLP is a structured system for study control and traceability. It supports confidence in how data were generated, reviewed, reported, and preserved.

References

1. FDA. Data Integrity and Compliance With Drug CGMP: Questions and Answers.
2. OECD Principles of Good Laboratory Practice.
3. ISO/IEC 17025 overview.

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TSMS Labs educational disclaimer: For laboratory research and educational purposes only. Not for human consumption. This content is not medical, clinical, or regulatory advice.