Getting To Good Laboratory Practice

Good Laboratory Practice (GLP) is a quality system for planning, performing, monitoring, recording, reporting and retaining nonclinical animal studies. Sticking to GLP ensures the validity of your nonclinical safety data – that it has integrity and reliability.

Learn about:

GLP history

Purpose and principles

When its required

Sticking to the guidelines

Drug development and GLP

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Frequently Asked Questions about the Insider’s Insight: Good Laboratory Practice

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What is Good Laboratory Practice (GLP)?

GLP is a quality system for planning, conducting, monitoring, recording, reporting, and archiving nonclinical laboratory studies. It ensures that safety data are reliable, reproducible, and ethically generated.

When is GLP compliance required in drug development?

GLP is generally required during the nonclinical stages of drug development, especially for studies needed before an IND/IMPD submission—such as repeated‑dose toxicity, genotoxicity, and safety pharmacology studies. Early exploratory studies may not require GLP compliance.

How can I tell if a study was conducted under GLP conditions?

GLP does not dictate the scientific methods used but provides the framework for how studies must be conducted. Study reports should clearly state GLP status, and audits from an independent Quality Assurance Unit (QAU) help verify compliance.

Where should the GLP status of a study be reported?

GLP status should be included in documents that summarise nonclinical studies, such as Investigator’s Brochures (IBs), INDs/IMPDs, and Common Technical Documents (CTDs).

What are common errors that lead to GLP non‑compliance?

Frequent issues that can compromise data integrity and GLP adherence include:
- Poor equipment calibration
- Inadequate documentation
- Improper use of PPE
- Misinterpretation or misrecording of data
- Lack of communication between researchers
- Not performing blinded assessments when required

Getting To Good Laboratory Practice

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Frequently Asked Questions about the Insider’s Insight: Good Laboratory Practice