WHO guidelines on crude drug standardization
Start with the big picture
Reliable evaluation starts by confirming the plant’s Latin binomial and family, supported by an authenticated herbarium voucher. GACP principles address origin, collection timing, plant part, maturity, and sustainable wildcrafting; GMP informs hygienic drying, handling, and storage. Macroscopic and microscopic examination can help identify adulteration or substitution, while physico-chemical tests, chromatographic fingerprints, and marker assays provide further quality evidence. The broader standardization framework also considers contaminants, microbial quality, volatile oil content where relevant, packaging, stability, and supply-chain records. Reference standards support routine quality control, and batches that show deterioration or fail specifications should be rejected. The lesson presents these elements as connected steps in evaluating crude drugs.
What you'll learn
- Explain how botanical authentication supports crude drug identity and traceability.
- Distinguish GACP collection practices from GMP post-harvest requirements.
- Identify examination and analytical approaches used to detect adulteration and assess quality.
- Describe the roles of contaminant testing, packaging, stability studies, and documentation.
- Recognize the purpose of reference standards and batch rejection criteria.
Continue your study
Work through the complete notes and reinforce the topic with the study tools available in the full lesson.
