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Open solicitation of guidelines for the production and processing of Chinese herbal medicines in Shanxi Province

 Last Update: 2022-10-19
 Source: Internet
 Author: User

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In accordance with the requirements of the General Department of the State Food and Drug Administration, the "Reply Letter on Issues Related to the Procurement of Chinese Materia Medica Materials from the Origin Processing (Cut While Fresh) by Chinese Medicine Pieces Manufacturers (NMP) (NMPA Comprehensive Drug Management Letter [2021] No.
367), our bureau has drafted the "Guidelines for Cutting and Processing of Traditional Chinese Materia Medica Producing Areas in Shanxi Province (Draft for Comments)" (see Annex 1), which is hereby released to the public for comments
.

The public consultation period is October 12-25, 2022
.
Concerned and individual feedback can be sent to the shengjuajc@163.
com
.

Contact number: 0351-8383544

Contact: Zhao Yongchang

Attachments: 1.
Guidelines for Fresh-cut Processing of Traditional Chinese Medicinal Materials in Shanxi Province (Draft for Comments)

2.
Template for Feedback Form

Shanxi Provincial Drug Administration

October 12, 2022

(Proactive disclosure)

Annex 1

Guidelines for the Fresh Cutting and Processing of Traditional Chinese Medicinal Materials in Shanxi Province (Draft for Solicitation of Comments)

1.
Scope of application

These guidelines are applicable to the whole process
of processing management and quality control/control of traditional Chinese medicinal materials in Shanxi Province.

II.
Principles

The processing of Chinese herbal medicines (cut while fresh) is closely related to the quality of Chinese herbal pieces, and its quality and technological flow should be strictly controlled/controlled
.
The source of traditional Chinese medicinal materials shall comply with the corresponding provisions of national or provincial standards, net selection, cutting, drying, etc.
shall be processed in accordance with the process regulations, and measures shall be taken to prevent deterioration and mildew, pollution and cross-contamination, confusion and errors in the process of cutting, drying, packaging, storage and transportation
.

3.
Personnel requirements

(1) Fresh-cut medicinal materials processing enterprises shall be equipped with corresponding management and technical personnel, and the management and technical personnel shall have more than 3 years of experience in the processing of Chinese medicinal materials and have the ability
to distinguish the authenticity of the varieties of Chinese medicinal materials processed by them.

(2) A special person shall be responsible for training management, and the content of the training shall include professional knowledge of traditional Chinese medicine, job skills, and knowledge of relevant laws and regulations
.

(3) Processing personnel who come into direct contact with fresh-cut medicinal materials shall undergo a health examination
before taking up their posts.
Persons with infectious diseases, wounds on the body surface, skin contact, etc.
who are allergic to processed fresh-cut medicinal materials shall not engage in the processing of
fresh-cut medicinal materials.

4.
Site selection requirements

Fresh-cut medicinal materials processing enterprises shall be set up in areas where the planting scale of traditional Chinese medicinal materials is large and relatively concentrated, and meet the requirements
of relevant laws and regulations such as environmental protection.

(1) It shall be far away from pollution sources, clean and hygienic, and have convenient
transportation.

(2) The ground, road surface and transportation of the factory area shall not cause pollution
to the processing of Chinese herbal medicines.

5.
Plant and facility requirements

(1) The plant and facilities shall be reasonably arranged according to the processing process, and a net selection, cutting, drying and other operation rooms
shall be set up that are suitable for their processing scale.

(2) The internal surfaces of the plant floor, walls, canopies and other internal surfaces shall be flat, easy to clean, not easy to produce shedding, and not easy to breed mold; There shall be facilities to prevent insects or other animals from entering, and rodenticides, insecticides, fumigants, etc.
shall not cause pollution
to equipment, materials and products.

(3) Have a hardening drying field (drying equipment or drying room suitable for the processing variety) suitable for the scale of processing, and there shall be facilities
to prevent insects, birds or rodents from entering.

(4) The warehouse shall be equipped with appropriate facilities, and effective measures shall be taken to control/control the temperature and humidity according to the characteristics of the varieties to ensure that Chinese medicinal materials, intermediate products and fresh-cut medicinal materials are stored
in accordance with regulations.

6.
Equipment requirements

(1) Equipment that can meet the requirements of processing technology shall be selected according to the needs of the different characteristics of Chinese herbal
medicines.

(2) Equipment, tools and containers that come into direct contact with Chinese herbal medicines, intermediate products and fresh-cut medicinal materials shall be easy to clean and disinfect, not easy to produce shedding, and shall not adversely affect
the quality of Chinese medicinal materials, intermediate products and fresh-cut medicinal materials.

(3) The water used for the production of fresh-cut medicinal materials shall at least meet drinking water standards and be monitored
regularly.

7.
Packaging and transportation requirements

(1) Packaging materials or containers
that can ensure their quality during storage and transportation shall be selected.
Fresh-cut medicinal materials shall have standardized packaging and labels, and shall be accompanied by a quality mark
.
Packaging materials or containers in direct contact should at least meet the requirements
for medicinal use.
The content of the label shall include: product name, specification, place of origin, harvest date, storage conditions, shelf life, name of the processing enterprise of origin, product batch number, processing date, and implementation standards
.

(2) Effective and reliable measures shall be taken during transportation according to the quality characteristics of Chinese medicinal materials and fresh-cut medicinal materials to ensure their stable
quality.

VIII.
Document Management Requirements

(1) There shall be corresponding fresh-cut medicinal materials product quality standards and processing technology, personnel management, raw material management, processing process management, warehousing management and other systems/degree documents
.

(2) The whole process of processing, drying, packaging and storage of Chinese herbal medicines at the production area (cut while fresh) and the quality control/control situation shall be recorded, and the batch records shall include at least the following contents: the name, batch number, feeding amount and feeding record of the Chinese herbal medicine; Equipment number for purification, cutting, drying and other processes; Records of pre-processing inspections and checks; Records of processing operations of each process; Clearance records, etc
.

9.
Processing management requirements

(1) Personnel entering the processing zone shall have cleaning protection and safeguard measures
.

(2) After cleaning/washing, Chinese herbal medicines shall not directly contact the ground
.
Effective anti-pollution measures
such as insect prevention and rain prevention shall be taken during the drying process.

(3) Flowing drinking water shall be used to clean/wash Chinese herbal medicines, and used water shall not be used to clean/wash other Chinese medicinal materials
.
Different Chinese herbal medicines shall not be cleaned/washed or infiltrated in the same container at the same time
.

(4) Bleaching, insecticides and other agents shall not be added during processing, and sulfur fumigation shall not be
abused.

(5) Take the date of feeding of Chinese medicinal materials as the processing date
.
A certain number of relatively homogeneous finished products processed in the same batch of Chinese herbal medicines in the same continuous processing cycle shall be used as a batch
.

(6) Isolation measures
to prevent cross-contamination shall be taken for the simultaneous production of fresh-cut medicinal materials of different varieties and specifications in the same operation room.

10.
Quality control/control and management requirements

(1) Chinese medicine pieces manufacturing enterprises shall supervise, control/control
the quality and source of fresh-cut medicinal materials.

(2) Enterprises producing Chinese medicine pieces shall, according to the characteristics of Chinese medicinal materials, formulate processing technology regulations and technical requirements, and conduct process verification
of the processing process of fresh-cut medicinal materials.
Process regulations and technical requirements include purification, cutting, drying, etc
.

(3) Enterprises producing Chinese medicine pieces shall formulate inspection standards for fresh-cut medicinal materials, which shall not be lower than the statutory inspection standards
for Chinese medicinal materials and pieces of the same variety.

(4) Enterprises producing Chinese medicine pieces shall retain samples
of purchased fresh-cut medicinal materials in accordance with regulations.

(5) Manufacturers of Chinese medicine pieces shall conduct an annual quality review and analysis of fresh-cut medicinal materials and report
them in their annual reports.

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