Method Validation & Quality Assurance

good laboratory practice

/ good LAB-ruh-tor-ee PRAK-tis /

Imagine a courtroom where every claim must be backed by dated, signed records that a stranger could follow years later to see exactly what happened. Good laboratory practice brings that same demand to the lab: it is a formal quality system that insists studies be planned, performed and recorded so thoroughly that an outsider could reconstruct and trust them long after the work is done.

Good laboratory practice is a defined set of principles — originally written for safety studies submitted to regulators — covering how a lab organises its people, facilities, equipment, written procedures, raw data and reports. It demands clear responsibilities, a quality-assurance unit that audits the work, full traceable records, and archived data, so that the integrity of a study can be verified independently.

It matters because regulators deciding whether a chemical, drug or pesticide is safe must be able to trust the underlying data completely, and good laboratory practice makes that data auditable and defensible. The honest caveat is that good laboratory practice is about the trustworthiness and traceability of records, not directly about scientific quality — a study can be perfectly compliant yet still be poorly designed.

Under good laboratory practice, a toxicology study testing a new pesticide keeps a signed study plan, dated raw-data sheets for every weighing and reading, calibration logs for each instrument, and an independent quality-assurance audit — so a regulator can re-trace every number years later.

A formal records system that lets outsiders reconstruct and trust a study.

Good laboratory practice (data integrity in non-clinical safety studies) is a different framework from good manufacturing practice and good clinical practice; the shared word good signals each is a regulator-recognised quality standard for its own domain.

Also called
GLP良好实验室操作规范良好實驗室規範GLP 規範