Good Manufacturing Practices (GMP) for Herbal Products

Schedule T of the Drugs and Cosmetics Rules establishes the Good Manufacturing Practice framework specifically applicable to Ayurvedic, Siddha, and Unani drug manufacture in India, adapting the general GMP principles familiar from synthetic pharmaceutical manufacture to the particular characteristics of traditional herbal dosage forms. Schedule T requires physically separate manufacturing areas for raw material storage, processing, and finished goods, together with an independent quality-control laboratory and documented pest-control measures; dosage-form-specific equipment validated and cleaned according to written procedures for each traditional preparation type, including powders (churna), decoctions (kwath), fermented preparations (asava-arishta), pills (vati), and semisolid confections (lehya); mandatory identity, purity, heavy metal, and microbial testing of every incoming raw material batch before its release for use in manufacture; documented in-process controls addressing moisture content, particle size, and blend uniformity at defined intermediate manufacturing stages; and finished-product release testing encompassing marker compound assay, physical testing, microbial limits, and heavy metal analysis, with a Certificate of Analysis generated for every batch. Comprehensive documentation, comprising Batch Manufacturing Records, written Standard Operating Procedures, calibration and training records, and a formal deviation-management log, underlies the entire Schedule T system, and — precisely mirroring the Good Laboratory Practice documentation principles introduced elsewhere in this text — a herbal product's regulatory acceptability rests as much on the completeness of its documentation as on the underlying manufacturing process itself.