Good Laboratory Practice (GLP) is a quality system used for organizing and managing non-clinical health and environmental safety studies. Its primary goal is to ensure the reliability, integrity, and quality of the data generated during these studies.
According to the principles, GLP defines a set of rules and criteria concerned with the organisational process and the conditions under which these studies are planned, performed, monitored, recorded, reported, and archived. This structured approach helps regulatory authorities trust the safety data submitted for products like pharmaceuticals, pesticides, cosmetics, and food additives.
Why is GLP Important?
The importance of GLP lies in ensuring that laboratory study data is reliable and reproducible, regardless of where it was generated. This allows regulatory bodies to confidently assess the potential risks of substances to human health and the environment without needing to re-perform the studies themselves.
- Data Integrity: GLP provides a framework to minimize errors and biases.
- Global Acceptance: Adherence to GLP standards facilitates the mutual acceptance of data between countries, reducing duplicate testing.
- Consumer Safety: Reliable data contributes to informed decisions about product safety.
- Animal Welfare: Reduces the need for repeated studies on animals.
Key Aspects of GLP
While the provided reference highlights the core scope, GLP principles typically cover several interconnected areas to maintain study quality:
- Organization and Personnel: Defining responsibilities, qualifications, and training.
- Facilities: Ensuring suitable size, construction, and location to prevent contamination and mix-ups.
- Equipment: Proper calibration, maintenance, and operation.
- Test and Reference Items: Characterization, handling, and storage.
- Standard Operating Procedures (SOPs): Detailed written instructions for all routine laboratory activities.
- Study Plan: A documented plan outlining the study objectives, methods, and procedures before the study begins.
- Study Conduct: Following the study plan and SOPs, documenting all observations and data accurately.
- Reporting: Producing a final report that accurately reflects the raw data.
- Archives: Secure storage of raw data, samples, specimens, and reports for a specified period.
The Study Lifecycle in GLP
Based on the reference, GLP governs the entire lifecycle of a study, from conception to completion and beyond:
| Stage | Description | GLP Principle Applied |
|---|---|---|
| Planned | Defining objectives, methods, and responsibilities | Study Plan (Protocol), Organisation, Personnel |
| Performed | Carrying out the study procedures | Study Conduct, Facilities, Equipment, Test/Reference Items |
| Monitored | Quality Assurance oversight during the study | Quality Assurance Unit (QAU) checks |
| Recorded | Documenting all data and observations accurately | Raw Data Capture, SOPs |
| Reported | Compiling results and conclusions | Final Report preparation, Data Integrity |
| Archived | Storing documentation and samples securely | Archive Management, Data Retention |
This systematic approach ensures that every step of a non-clinical health and environmental safety study is controlled and documented, providing a robust basis for safety assessment.
