 Home > Medical News > Latest Medical News > Heilongjiang Province regulates the guidance on the processing of traditional Chinese medicinal materials (cut while fresh).

Heilongjiang Province regulates the guidance on the processing of traditional Chinese medicinal materials (cut while fresh).

 Last Update: 2022-10-20
 Source: Internet
 Author: User

Tags

hemostat medicine

crayton drug

Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com

In accordance with the requirements of the "Reply of the Comprehensive Department of the State Food and Drug Administration on Issues Related to the Procurement of Origin Processing (Cut While Fresh) Chinese Materia Medica by Manufacturers of Traditional Chinese Medicine Pieces" (NMPA Comprehensive Drug Management Letter [2021] No.
367), our bureau has organized and completed the drafting of the "Heilongjiang Province Guiding Opinions on Standardizing the Processing of Traditional Chinese Materia Medica Origins (Cut While Fresh)", which is now open for comments
.
Please submit amendments or suggestions within 10 working days and give feedback
in writing or by email.

Contact: Zhang Di, 0451-82610871;

Mailing address: Room 103, Heilongjiang Provincial Drug Administration, No.
76, Bank Street, Nangang District, Harbin;

Email: 249229502@qq.
com
.

Attachment: Guiding Opinions of Heilongjiang Province on Regulating the Processing of Traditional Chinese Medicinal Materials (Cut While Fresh)

Heilongjiang Province regulates the guidance on the processing of traditional Chinese medicinal materials (cut while fresh).

In order to implement the requirements of the "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Innovation and Development of Traditional Chinese Medicine", "Implementation Opinions of the State Food and Drug Administration on Promoting the Innovation and Development of Traditional Chinese Medicine" and "Development Plan of Traditional Chinese Medicine Industry in Heilongjiang Province", regulate traditional Chinese medicinal materials in our province The behavior of processing (cutting while fresh) in the production area, controlling the quality of traditional Chinese medicine from the source, promoting the integrated development of processing and processing of traditional Chinese medicinal materials, improving the market competitiveness of the traditional Chinese medicinal materials industry, promoting the high-quality development of the traditional Chinese medicine industry, improving the quality of traditional Chinese medicinal materials and pieces of traditional Chinese medicine, and ensuring the safety of people's medicine, the following guiding opinions
are hereby put forward to standardize the processing of traditional Chinese medicinal materials in our province (cut while fresh).

First, the work objectives

In order to strengthen the management of the production area of Chinese herbal medicines, mainly Heilongjiang authentic Chinese medicinal materials and bulk real estate Chinese medicinal materials, solve the loss and loss of ingredients due to "secondary infiltration" cutting and manufacturing in the process of processing Chinese medicinal materials in traditional Chinese medicine production enterprises, explore the effective docking of processing and concoction of production areas, incorporate the planting (breeding), harvesting, processing and other processes of traditional Chinese medicinal materials into the quality management system of pharmaceutical production enterprises, implement the main responsibility of enterprises, and improve the quality control level of
the whole industrial chain of traditional Chinese medicine.

2.
Scope of application

These Guiding Opinions
shall apply to the activities of traditional Chinese medicine production enterprises in Heilongjiang Province to carry out the activities of freshly cut Chinese medicinal materials (hereinafter referred to as fresh-cut medicinal materials) produced by production area processing enterprises with a sound quality management system and their supervision and management.

Fresh-cut medicinal materials refer to the primary processing of fresh Chinese medicinal materials harvested into pieces, segments, blocks, silks, peeled, coreed and other non-medicinal parts in accordance with traditional processing methods in the production area of traditional Chinese medicinal materials
.
Processing (cutting while fresh) can only change the form of Chinese herbal medicines, and should not change the properties of
Chinese medicinal materials.
The variety should be within
the scope of the catalog published by the provincial drug administration.

3.
Formulate a catalogue of varieties processed (cut while fresh).

Based on the authentic Chinese medicinal materials that have large-scale planting (breeding) and processing in our province, as well as other varieties suitable for fresh-cut and processing of traditional Chinese medicinal materials, according to the "Chinese Pharmacopoeia", "Heilongjiang Province Standards for Traditional Chinese Medicinal Materials" and "Heilongjiang Province Chinese Medicine Pieces Concoction Specifications and Standards", the "Heilongjiang Province Traditional Chinese Medicine Pieces Concoction Specifications and Standards" included varieties of Chinese medicinal materials, the "Heilongjiang Province Origin Processing (Fresh Cutting) Chinese Medicinal Materials Varieties Catalogue" (Annex 1, hereinafter referred to as the "Catalogue")
is formulated.
According to the needs of planting (breeding) and use, the catalogue of varieties of processed (freshly cut) Chinese medicinal materials (hereinafter referred to as fresh-cut medicinal materials) in the production area is regularly adjusted
every year.

4.
Standardize the processing (cutting while fresh) at the production area

Traditional Chinese medicine production enterprises in the production areas of traditional Chinese medicinal materials in the province may build their own production area processing enterprises (processing workshops) to carry out self-collection and self-production or purchase fresh-cut medicinal materials listed in the Catalogue from production area processing enterprises for pharmaceutical production
.
The processing of Chinese herbal medicines shall be carried out
with reference to the relevant provisions of the Good Manufacturing Practice for Medicines and its Appendix to Chinese Medicine Pieces.

(1) Strengthen self-collection/self-production quality management

If a traditional Chinese medicine production enterprise applies to set up a fresh processing production line or a remote workshop, it shall apply to the provincial bureau for a change in the drug production license, and if it meets the requirements, it shall be stated
in the copy of the "Drug Production License" in accordance with the law.

Traditional Chinese medicine manufacturing enterprises shall carry out self-collection and self-production of self-collection and self-production, shall evaluate their quality assurance capabilities and risk management capabilities, and after self-inspection and meet the requirements of fresh cutting, they shall inform the provincial food and drug administration of the audit and evaluation report and the list of reports on the production area of Chinese herbal medicines (Annex 2), and list
them in the annual drug report.

1.
Establish standards and process regulations

(1) Chinese medicine manufacturers should formulate their own quality standards for freshly cut Chinese medicinal materials (Annex 3, Quality Standard for the preparation of quality standards) that are compatible with the quality standards of Chinese medicine pieces, as the internal control standard of the enterprise, the fresh-cut medicinal materials standard shall be supported by sufficient test data, and its base and quality (except form) shall not be lower than the provisions of the Chinese Pharmacopoeia, the Heilongjiang Province Standards for Chinese Materia Medica, and the Heilongjiang Province Standards and Standards for the Preparation of Traditional Chinese Medicine Pieces.
Encourage production enterprises to formulate internal control quality standards that are higher than statutory standards
.

(2) Traditional Chinese medicine manufacturers shall formulate the process regulations and technical requirements for cutting while fresh according to the varieties, including net separation, slicing, drying and packaging processes, and their cutting and processing technology shall be verified and confirmed
by test or trial production.
During processing, the process flow shall be strictly implemented and truthfully recorded, and complete production and processing records shall be established and retained to ensure the traceability
of the processing process of Chinese herbal medicines while they are fresh.

2.
Establish a quality management system Chinese medicine production enterprises production area while the processing conditions are fresh cut and processing conditions shall be compatible with the variety and scale of processing, and at the same time have a sound quality management system, equipped with sufficient professional technology, quality management personnel and necessary cleaning, sorting, cutting, drying, screening, storage and other facilities and equipment
.
Strictly implement the process and quality standards of fresh cutting, establish complete and accurate batch production records, and ensure the traceability
of the whole process of processing, storage and sales of Chinese herbal medicines while fresh.

(3) Fresh-cut medicinal materials shall have standardized packaging and labels, with quality quality labels
.
Packaging materials that come into direct contact with fresh-cut herbs should at least meet the standards for
food packaging materials.
The content of the label should be consistent with the expression of the enterprise's internal control standards, and should at least include: product name, specification, quantity or weight, origin (obvious medicinal materials in the authentic area can be marked to municipal districts and counties), harvesting time, product batch number, storage, processing point (enterprise) name, etc.

The re-inspection period
can be determined according to the product characteristics, packaging form, quality inspection and other factors of fresh-cut medicinal materials.
Fresh-cut medicinal materials that have not passed the re-inspection after the re-inspection period shall not be used in the production of
drugs.
Under the product name, "fresh-cut medicinal materials" should be noted in parentheses, such as "product name: huanglian (fresh-cut medicinal materials)"
.

The production line or workshop set up by non-Chinese medicine manufacturers shall refer to the above content and improve the production quality management in
accordance with the quality requirements of Chinese medicine manufacturers purchasing fresh-cut pharmaceutical materials.

(2) Compacting the main responsibility of Chinese medicine manufacturing enterprises for the purchase of fresh-cut medicinal materials

1.
Traditional Chinese medicine production enterprises shall bear all quality responsibilities for the purchase of fresh-cut medicinal materials, shall review the processing conditions, technical level and quality management of the supplier, confirm that they have the conditions and ability to take advantage of fresh processing, the technical and quality documents of the purchased varieties meet the requirements, can organize production according to order standards, and shall regularly carry out supplier audits to ensure that they continue to meet the requirements
.

2.
Chinese medicine manufacturers purchasing fresh-cut medicinal materials shall sign a quality assurance agreement with the supplier, and the supplier shall set up fresh-cut medicinal materials processing points
for large-scale Chinese herbal medicine planting enterprises or farmers' professional cooperatives.

3.
Traditional Chinese medicine manufacturers that purchase fresh-cut medicinal materials shall extend their quality management system to the planting, harvesting and processing of fresh-cut medicinal materials purchased, effectively do a good job in quality assessment, inspection and production process monitoring of fresh-cut medicinal materials, and list the relevant situation
in the annual drug report.

4.
Traditional Chinese medicine manufacturers shall bear the responsibility for quality management of the purchased fresh-cut medicinal materials, and shall put the fresh-cut medicinal materials into the warehouse for acceptance, and carry out production and processing such as purification and cannoning in accordance with the GMP requirements of traditional Chinese medicine pieces and national drug standards or provincial (autonomous region or municipality directly under the central government) specifications for the preparation of traditional Chinese medicine pieces, and can only be sold and used
after passing the inspection.

5.
Traditional Chinese medicine production enterprises shall further improve the information traceability system on the basis of quality traceability of production processing enterprises to ensure that the purchased fresh-cut medicinal materials can be traced and queried
in the whole process of planting, harvesting, processing, drying, packaging, warehousing, production and sales.

6.
The fresh-cut medicinal materials purchased by Chinese medicine manufacturers shall have packaging and labels
that meet the requirements of point 2 (2) of item (1) of this section.

5.
Standardize the procurement of processed medicinal materials

Chinese medicine manufacturers purchasing fresh-cut medicinal materials shall comply with the principle of "necessary, feasible, controllable and traceable", and purchase from production processing points with a sound quality management system
in accordance with the requirements of these guiding principles and the appendix "Quality Management Guidelines for Origin Processing (Fresh-cut) of Chinese Materia Medica".
Fresh-cut herbs shall not be purchased from various Chinese herbal medicine markets or individuals for the production of Chinese medicine pieces; Fresh-cut medicinal materials shall also not be purchased from production area processing enterprises with imperfect quality management systems or do not have a quality management system for the production of Chinese medicine pieces; The purchased fresh-cut herbs shall not be directly packaged and sold
as Chinese medicine pieces.

6.
Job requirements

(1) Implement entity responsibility

As the main body responsible for the quality of medicines, Chinese medicine production enterprises shall extend the quality management system to the standardized planting, harvesting, processing, drying, packaging, storage and other links of fresh-cut medicinal materials, improve the quality management system, perform quality management duties, and ensure that the quality of purchased fresh-cut medicinal materials meets the requirements
.

(2) Strengthen supervision and management

Strengthening the quality supervision of Chinese herbal medicines and standardizing the processing of production areas is a completely new task
.
Drug regulatory departments at all levels should strengthen the supervision of Chinese medicine production enterprises to strictly prevent Chinese medicine pieces that do not meet the requirements and fake/counterfeit and inferior Chinese medicine pieces from entering the market
.
If it is discovered that illegal acts such as the production and sale of fake and inferior Chinese medicine pieces are discovered, they shall be strictly investigated and dealt with
in accordance with laws and regulations.

(3) Strengthen co-governance and sharing

Drug regulatory departments at all levels should actively explore the management mode of processing (cutting while fresh) of Chinese medicinal materials, strengthen communication and coordination with relevant departments such as agriculture and rural areas, health and health, and Chinese medicine management, realize the sharing of information on the processing of traditional Chinese medicinal materials, promote the establishment and improvement of traceability systems for traditional Chinese medicine production enterprises, further ensure the quality and safety of traditional Chinese medicine, and promote the high-quality development of
the traditional Chinese medicine industry in our province.

Attachment: 1.
Catalogue of varieties of traditional Chinese medicinal materials processed (cut while fresh) in Heilongjiang Province

2.
List of reports on the production area of Chinese herbal medicines

3.
Requirements for the preparation of quality standards for fresh-cut medicinal materials

Annex 1 Catalogue of varieties of freshly cut Chinese medicinal materials from Heilongjiang Province

1.
Herbal slices (29 varieties in total): eleuthero, ginseng, American ginseng, red peony, white peony, yellow essence, astragalus, skullcap, banlan root, parsnip, white fresh peel, grass wu, aconite, ground elm, bitter sophora, mulberry branch, wolf poison, chai hu, bellflower, codonopsis, deer antler velvet, licorice, cangshu, tian/hemp, mulberry yellow, guanhuangbai, zhimu, beidou root, artemisia
.

2.
Cutting of medicinal herbs (a total of 9 varieties): motherwort, mistletoe, nightshade, rejuvenating grass, perilla stalk, tyrannomartin, dandelion, artemisia annua, plantain
.

3.
Core removal of medicinal herbs (2 varieties in total): Yuanzhi and lotus seeds
.

Appendix 2 List of reports on the production area of Chinese herbal medicines

1.
List of reports to be submitted for self-harvesting/processing of Chinese herbal medicines in the place of origin:

1.
Report form on the production area of Chinese herbal medicines;

2.
Process regulations and quality standards for freshly processed varieties;

3.
Catalogue of freshly processed varieties of origin;

4.
Self-inspection report
of the production enterprise.

II.
List of reports to be submitted by the agreement to entrust the origin processing enterprise to carry out the production area of Chinese herbal medicines:

1.
Report form on the production area of Chinese herbal medicines;

2.
Entrusted processing agreement;

3.
Quality assurance agreement;

4.
Process regulations and quality standards for freshly processed varieties;

5.
Entrust the catalogue of fresh processed varieties from the production area;

6.
Information certification file of origin processing enterprise;

7.
Self-inspection report
of the production enterprise.

This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.