Jiangxi Provincial Food and Drug Administration issued a notice to further strengthen the production management of Chinese herbal medicine pieces

On February 24, the Jiangxi Provincial Food and Drug Administration issued a notice to further strengthen the management of the production of fresh Zhuli Chinese herbal medicine pieces
.
Manufacturers are required to establish a traceability system for decoction pieces, report the production process, and fulfill the obligations of the holder.
At the same time, they are required not to produce without application.
The production of directly oral fresh Bamboo Li decoction pieces should also obtain the varieties of fresh Bamboo Li decoction pieces and direct oral Chinese medicine decoction pieces.
Production license, the production process should meet the relevant requirements of GMP and appendix
.
The original text is as follows: Relevant units: Our province is rich in bamboo resources and has a long history of fresh bamboo production
.
Fresh Bamboo Lek Chinese Herbal Decoction Pieces (hereinafter referred to as Fresh Bamboo Lek Decoction Pieces), as a characteristic large variety in our province, has the functions of clearing away heat and resolving phlegm, relieving shock and invigorating orifices
.
In order to further improve and strengthen our province's Fresh Bamboo Lek Chinese herbal medicine pieces, ensure clinical efficacy, prevent product quality risks, and enhance the brand value of Gan-produced Chinese herbal medicine pieces, we are now in accordance with the "Pharmaceutical Administration Law of the People's Republic of China" and the "Measures for the Supervision and Administration of Drug Production", etc.
According to the regulations, the notice on further strengthening the production quality management of fresh Zhuli Chinese herbal medicine pieces in our province is as follows: 1.
Implement the main responsibility of the enterprise.
Process management, establish a traceability system for Chinese herbal pieces, to ensure the safety, effectiveness and traceability of Chinese herbal pieces
.
2.
Implementing strict quality standards The fresh bamboo leaching standard was first included in the "Pharmacopoeia of the People's Republic of China" (1977 edition), and was later revised by the Ministry of Health.
Volume 1 (1992 edition)
.
The standard stipulates that the preparation method of fresh bamboo leaching is: the liquid naturally leached from the fresh stalks of the graminaceous plant powder green bamboo PhyllostachysglaucaMcClure, the net bamboo PhyllostachysnudaMcClure and several plants of the same genus after heating
.
The production enterprises of fresh Bamboo Li decoction pieces must strengthen the management of raw material sources, fix the source and origin of powder green bamboo, pure bamboo and the same plants, and formulate internal control quality standards for enterprises
.
The provincial bureau will continue to organize and carry out the improvement and revision of the quality standards for fresh bamboo leeches
.
3.
Strengthening the management of production licenses Fresh bamboo decoction pieces manufacturers must feed fresh bamboo, have complete production capacity, report to the Provincial Food and Drug Administration and confirm the process, and obtain the production range of fresh bamboo decoction pieces
.
For the production of fresh Bamboo Lek decoction pieces for direct oral administration, the production license for the varieties of fresh Bamboo Lek decoction pieces and direct oral Chinese medicine decoction pieces should be obtained at the same time, and the production process should comply with the relevant requirements of GMP and appendix
.
Without reporting and applying to the provincial bureau, it is not allowed to produce fresh bamboo leeks without authorization
.
The production enterprises of fresh bamboo leeches can set up production workshops in different places for the pre-processing of fresh bamboo leeks.
The establishment of pre-treatment workshops in different places shall be handled in accordance with the first point of Article 5 (1) of the "Implementation Rules for the Issuance of Drug Production Licenses in Jiangxi Province"
.
Pre-processing workshops established in different places shall not share the raw material production line of fresh bamboo leeks with other Chinese herbal decoction pieces production enterprises
.
Fourth, strengthen supervision and management Drug supervision and management departments at all levels should strengthen supervision and inspection to ensure that national standards are effectively implemented
.
In particular, supervise Chinese herbal medicine enterprises to strictly implement the requirements of the current national standards for fresh bamboo leeches, and strictly prohibit the production (including decoction and blending) of fresh bamboo leeks that do not comply with the national standards
.
5.
Specifications and labels The instructions and labels of direct oral fresh Bamboo Lek decoction pieces should be written and designed with reference to the "Administrative Regulations on Drug Instructions and Labels" of the State Food and Drug Administration
.
The product name, place of origin, specifications, manufacturer and its address, product batch number, production date, validity period, functions and indications, usage and dosage, etc.
should be indicated
.
The words in the labels and instructions should be clear, and the production date, expiration date and other matters should be marked prominently for easy identification
.
If you encounter new situations or problems during the implementation process, please report to the Chinese Medicine Supervision Department of the Provincial Food and Drug Administration in a timely manner
.