ISO 4904

2023-04-1806
ISO/DIS FDIS 4904:2023(E)
ISO/TC 249/SC 0/WG 2
Secretariat: SAC
Traditional Chinese Medicinemedicine — Inner pack of decoction pieces

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ISO/DIS FDIS 4904:20222023(E)
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ii © ISO 2022 2023 – All rights reserved

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ISO/DIS FDIS 4904:20222023(E)
Contents Page
Contents . iii
Foreword . iv
Introduction . v
1 Scope . 6
2 Normative references . 6
3 Terms and definitions. 6
4 Physical properties requirements for inner pack of decoction pieces . 8
5 Requirements for inner pack materials of decoction pieces . 8
6 Setting of packing dose specifications . 9
7 Requirements for labels. 10
8 Requirements for Quick Response (QR) codes . 11
9 Requirements for Colour codes . 11
Annex A (informative) Specifications and Corresponding Colour Codes for inner pack of
Decoction pieces . 13
Bibliography . 14
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ISO/DIS FDIS 4904:20222023(E)
Foreword
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Medicinemedicine.
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iv © ISO 2022 2023 – All rights reserved

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ISO/DIS FDIS 4904:20222023(E)
Introduction
Packing material used for the inner pack of decoction pieces should meet basic quality criteria, because
the inner packaging comes into direct contact with the decoction pieces. At present, there are no
internationally recognized standards that define the specifications for inner packaging. Therefore, the
inner packaging is often not standardized, not in compliance with hygienic requirements, not suitable
for the packaging of medicines and not applicable to the nature of decoction pieces. Hence, the inner
pack should be standardized to ensure the quality, safety and efficacy of decoction pieces.
In view of the current situation where there is often no inner pack of decoction pieces or the inner pack
is not in compliance with relevant requirements, this document will promotepromotes the
harmonisation of packaging for decoction pieces, leading to reduced trade barriers. This document,
along with ISO 18668-1, ISO 18668-2 and ISO 20333, can promote the process of standardization,
informatization and modernization of Chinese medicines.
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FINAL DRAFT INTERNATIONAL STANDARD ISO/DIS FDIS 4904:20222023(E)

Traditional Chinese medicine — Inner pack of decoction pieces
1 Scope
This document specifies requirements for the inner pack of decoction pieces of Chinese medicines,
including packaging materials, physical properties, specifications and labels.
This document is applicable to the manufacturing, inspection, operation, circulation, use, supervision
and management of inner pack of decoction pieces.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11615, Health informatics — Identification of medicinal products — Data elements and structures for
the unique identification and exchange of regulated medicinal product information
ISO 15378, Primary packaging materials for medicinal products — Particular requirements for the
application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 18668-1:2016, Traditional Chinese medicine — Coding system for Chinese medicines — Part 1: Coding
rules for Chinese medicines
ISO 18668-2, Traditional Chinese medicine — Coding system for Chinese medicines — Part 2: Codes for
decoction pieces
ISO 20333, Traditional Chinese medicine — Coding rules for Chinese medicines in supply chain
management
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or
topical use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 23963-1, Traditional Chinese medicine — Requirements for process traceability systems in Chinese
materia medica and decoction pieces — Part 1: Components
ISO 23963-2, Traditional Chinese medicine -— Requirements for process traceability system of Chinese
materia medica and decoction pieces — partPart 2: Electronic labelling
ASTM D3981, Standard specification for polyethylene films made from medium-density polyethylene for
general use and packaging applications
ASTM D4635, Standard specification for plastic films made from low-density polyethylene and linear low-
density polyethylene for general use and packaging applications
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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ISO/FDIS 4904:2023(E)
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at https://www.electropedia.org/
3.1
inner pack
package in direct contact with decoction pieces (3.2)
3.2
decoction piece
prescription medicinalsmedicinal processed from Chinese materia medicaMateria Medica in accordance
with traditional Chinese medicine and processing methods for Chinese medicines, which can be directly
used in clinical practice or the production of prepared medicines
[SOURCE: ISO 18668-1:2016, 3.3], modified — "under guidance" replaced by "in accordance with". Note
1 to entry has been merged into the definition.]
3.3
colour code
different colours used on the package or label of decoction pieces (3.2) for indicating different
specifications, including colour card (3.4) number, RGB and HEX/HTML
3.4
colour card
specific colour definitions are provided by different companies and are used for colour communication
systems in various areas, including printing, textile, plastics, drawing and digital technology
3.5
inner pack materials
materials that meet the requirements of this document, which are used to manufacture the packaging
bags which are in direct contact with the decoction pieces (3.2)
4 Physical propertiesproperty requirements for inner pack of decoction pieces
4.1 Shall complyThe physical properties shall be in accordance with ISO 15378, ASTM D3981, and
ASTM D4635 and ISO 15378. Bags for the inner pack of decoction pieces shall be sealed air tight and the
surface shall be clean and without any damage, aging andor foreign matter attachingattached,
delamination andor other abnormalities.
4.2 Visual inspection shall be under natural light, the surface of packaging should be smooth without
pleats.
4.3 For continuous inner packaging, the connection part between two adjacent packages should be
transparent and its length shall be ≥20 mm.
4.4 For high-cost decoction pieces, effective measures such as double packaging shall be taken to avoid
losses and contamination resulting from damaged packaging in the process of storage and
transportation due to loading and unloading collision.
EXAMPLE High-cost decoction pieces may include Ophiocordyceps sinensis also commonly known as
Cordyceps sinensis, Panacis ginseng, Gastrodia elata and other similar decoction pieces.
4.5 Decoction pieces for toxic, anesthetic and psychotropic shall be double packaged and marked
notably with a corresponding warning sign on the inner pack.
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ISO/FDIS 4904:2023(E)
EXAMPLE Decoction pieces for toxic, anesthetic and psychotropic uses may include realgar, Datura
stramonium flower, Aconitum brachypodum root and other similar ones.
5 Requirements for inner pack materials of decoction pieces
5.1 Inner pack materials shall be purchased from qualified manufacturing enterprises, which obtained
a licence to produce packaging material for food and medical use. Toxic materials with "chlorine" and
recycled toxic materials shall be prohibited. I
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