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Working group operations: WG2
6 December 2012
Dr Wendy Morrow HE-031 Committee Member
WG2 –
Quality and safety
of manufactured
TCM Products
ISO/TC 249 WG2 established at 2nd Plenary meeting, the Hague, May 2011
Chaired by Dr Sven Schröder (HanseMerkur Centre for TCM, University of Hamburg)
1st meeting April, 2012 in Berlin, Hosted by DIN Germany
2nd meeting as part of 3rd Plenary meeting, Daejeon, Korea, May 2012
3rd meeting October, 2012 in Berlin, Hosted by DIN Germany
Membership Eleven active members include:
– China (PRC)
– Korea (ROK)
– Japan
– USA
– Netherlands
– Australia
– South Africa
– Italy
– Canada
– Singapore
– Thailand
Differentiating the Scope of WG1 and WG2
from Resolution 18 of the 2nd Plenary Meeting
Working Group 1 - raw materials
– To create standards related to natural
materials at any stage up to and including
harvest of a plant ingredient and collection of
an animal or mineral ingredient.
Working Group 2 - manufactured products
– To create standards related to processing of
natural materials or manufacturing of products
made with natural materials.
Differentiating the Scope of WG1 and WG2
Scope of WG2
The scope of WG2 shall be the standardization of
testing, processing (other than traditional
processing) and manufacturing of TCM products,
from starting materials to finished products, in a
framework of quality and safety.
WG2 will also be responsible for the ongoing
maintenance and development of standards
produced.
Project Priorities Quality Control Framework for Manufactured TCM
Products
Requirements for Manufacturing TCM Products
Requirements of Manufacturing Process for Red
Ginseng
1st Project
Quality Control
Framework for
Manufactured
TCM Products
Action to date
Agreed to the proposal in general
Asked for further development, and that all
delegates discuss the proposal with their national
experts and send their comments before 2012-12-
31
Project editor of this PWI to revise the proposal
before 2013-01-31
Decided to further develop this proposal at the
next meeting
2nd Project
Requirements
for
Manufacturing
TCM Products
Action to date
Agreed to the idea of the proposal
Asked the proposer for further development of the
proposal - taking relevant resources from China,
Korea, Australia, Canada, USA, Europe and other
countries on GMP into account
Work close together with the proposers of the
manufacturing process for Red Ginseng (3rd
Project) to harmonize the general and the specific
requirements on manufacturing
Asked all delegates to discuss this proposal with
national experts and send their comments before
2012-12-31
Asked the project editor of this PWI to revise the
proposal before 2012-01-31
Decided to further develop this proposal at the
next meeting
3rd Project
Requirements of
Manufacturing
Process for Red
Ginseng
Action to date
Agreed to the idea of the proposal
Asked the proposer for further development of the
proposal taking into account the boundaries
between WG1 and WG2.
Agreed it could be used as an example for the
practical application and specification of the
general requirements of the manufacturing
process for a specific product.
Agreed that after the consultation and a
consensus, to send this revised proposal to the
secretariat of ISO/TC 249 starting the NP ballot
Asked all delegates to discuss this proposal with
national experts and send their comments before
2012-12-31
Asked the project editor of this PWI to revise the
proposal before 2012-01-31
Local WG2 Members invited and have agreed to participate
Inactive at this point in time
Plan to activate the WG this month due to upcoming work
THANK YOU