21/30379307 DC

This standard 21/30379307 DC BS ISO 23419. Traditional Chinese medicine. General requirement of manufacturing procedure and its quality assurance for granules is classified in these ICS categories:

• 11.120.10 Medicaments

This document specifies general requirements for manufacturing procedures and quality and safety assurance of granules and compactates made from TCM extracts or powder for oral use. This document excludes granules or compactates made from pure compounds (chemically defined) even if they are isolates as naturally occurring constituents of decoction pieces or crude herbal and mineral drugs.