21/30379307 DC - BS ISO 23419. Traditional Chinese medicine. General requirement of manufacturing procedure and its quality assurance for granules

21/30379307 DC

BS ISO 23419. Traditional Chinese medicine. General requirement of manufacturing procedure and its quality assurance for granules

Published : April 2021

Format
PDF

Format
HARDCOPY



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.




Standard Number21/30379307 DC
TitleBS ISO 23419. Traditional Chinese medicine. General requirement of manufacturing procedure and its quality assurance for granules
Publication Date02 April 2021
Normative References(Required to achieve compliance to this standard)ISO 21317, ISO 19617, ISO 18864, ISO 19609-1
Informative References(Provided for Information)ISO 22283, ISO/DIS 22467, ISO/DIS 23723, ISO 22258
Draft Expiry Date26 May 2021
DescriptorsSafety, Quality assurance, China, Manufacturing, Medicines
ICS11.120.10
Title in FrenchTitre manque
CommitteeCH/100/1
PublisherBSI
FormatA4
DeliveryYes
Pages23
File Size354 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


Worldwide Standards
We can source any standard from anywhere in the world


Tracked Changes

Understand the changes made to a standard with our new Tracked Changes version


Develop a PAS

Develop a fast-track standardization document in 9-12 months