What is the Origin of Good Laboratory Practice (GLP)?

GLP regulations were established in the United States in the 1970s following reports of poor quality and fraudulent practices in some toxicology laboratories. The primary goal was to ensure the trustworthiness of safety data used to make critical public health decisions about new chemicals and drugs. This standardized framework provides the foundational assurance that the hormonal compounds being tested are evaluated under verifiable and documented conditions before they proceed to human trials.

What is the Mechanism of Good Laboratory Practice (GLP)?

GLP operates by mandating comprehensive documentation and systematic controls over every aspect of a non-clinical study, including the facility, equipment, personnel, methods, protocols, and records. It requires the establishment of a Quality Assurance Unit (QAU) to independently monitor the study process and ensure the final report accurately reflects the raw data. This rigorous mechanism prevents bias and error, safeguarding the integrity of the crucial safety profile for any potential new hormonal therapy.

Good Laboratory Practice (GLP) ∞ Area

Good Laboratory Practice (GLP)

Meaning

A quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of non-clinical safety tests. GLP specifically applies to in vitro and in vivo toxicology and safety studies that support the regulatory approval of health products, including new hormonal compounds. Adherence to these strict protocols is mandatory for all preclinical research data submitted to regulatory bodies like the FDA.