Good Laboratory Practices (GLP) in Herbal Drug Testing

Good Laboratory Practice, as applied to herbal drug testing, extends the same organisational and documentation discipline described for synthetic drug toxicology testing to the preclinical safety studies required for a new phytopharmaceutical drug submission. Every acute, sub-chronic, and chronic toxicity study, together with any genotoxicity or reproductive toxicity study conducted in support of a New Phytopharmaceutical Clinical Drug submission, must be performed under full GLP conditions in an accredited testing facility, with an independent quality assurance function, a designated Study Director, validated and calibrated analytical instrumentation, and complete raw-data retention for the standard regulatory retention period. GLP compliance is distinct from, and in addition to, Schedule T manufacturing GMP compliance: GMP governs the manufacture of the herbal product itself, while GLP governs the generation of the analytical and toxicological data submitted in support of its regulatory approval, and both are independently audited by regulatory inspectors as part of the overall dossier review process.