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