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On November 29, the Zhejiang Provincial Food and Drug Administration issued a notice of the third phase of Zhejiang Province Drug Quality Sampling Inspection Announcement in 2021.
According to the list of drugs that did not meet the standard requirements for the supervision and sampling inspection, a total of 8 batches of drugs did not meet the requirements for the random inspection.
Chinese Herbal medicine involving multiple batches, comprising a non-compliant projects] [check the amount of difference, dissolution [], [] to check the amount of ethanol, Determination of content, the weight difference [], [] characters and the like
.
The 8 batches of unqualified medicines investigated and dealt with include three batches of Chinese patent medicines: Nanbao capsules, Huoxiang Zhengqi water, and Yinao tablets; three batches of Chinese medicine decoction pieces of Fritillaria vulgaris, Jigucao, and safflower, and omeprazole enteric-coated Two batches of western medicine, capsules and berberine hydrochloride tablets
.
From the point of view of the labeled manufacturers, a certain decoction piece company has failed to pass the two varieties of chicken bone grass and zhe fritillary
.
It is understood that the pharmaceutical company has repeatedly been exposed to produce substandard drugs.
Since 2018, there have been 8 batches of unqualified drugs.
On November 10 this year, the Zhejiang Fritillaria produced by the pharmaceutical company was also detected as substandard.
In addition, in January this year, the pharmaceutical company was found to have 1 serious defect, 1 major defect, and 10 general defects during the daily inspection, which did not meet the requirements of GMP (Good Manufacturing Practice).
He was warned, interviewed and ordered to make rectification within a time limit
.
Another decoction piece company has repeatedly "stepped on thunder".
Since 2018, the company has had 46 batches of drugs found to be unqualified, of which 6 batches have been convicted of counterfeit drugs
.
For these decoction pieces enterprises, under the implementation of the new version of the Drug Administration Law, the production and sales of counterfeit and inferior drugs will bear an extremely high price.
For the long-term stable development of the enterprises, it is urgent to strengthen the quality supervision of production links
.
On October 9 this year, the Zhejiang Provincial Food and Drug Administration issued the second phase of the 2021 drug quality announcement.
There were 10 batches of unqualified drugs, of which nearly half of the unqualified drugs were decoction pieces of traditional Chinese medicine
.
It can also be seen from this list that proprietary Chinese medicines and decoction pieces of Chinese medicine are still the "severe disaster areas" where medicines are unqualified
.
In addition to Zhejiang Province, looking back at this year, news about the unqualified sampling of Chinese herbal medicines also appeared in the notices of local drug administrations
.
For example, on October 29, the Yunnan Provincial Food and Drug Administration issued a 2021 Phase 3 Drug Quality Announcement
.
This time, 21 batches of drugs from 13 drug manufacturers were found to be unqualified, including 18 batches of Chinese herbal medicine pieces, which accounted for 80% of this unqualified list
.
On October 27, the Hebei Provincial Food and Drug Administration issued the 2021 Phase 3 Drug Quality Announcement.
This time, two batches of TCM decoction pieces were found to be unqualified
.
On October 18, in the drug quality announcement issued by the Chongqing Drug Administration, 4 batches of Chinese herbal medicines were unqualified, including Shouwu vine, leech, ginseng, and gastrodia superfine powder
.
The industry pointed out that the traditional Chinese medicine decoction pieces industry is developing rapidly, but the accompanying quality problems are also very prominent.
Because the decoction pieces themselves are not easy to store, and the quality control in the production process is difficult, many companies are "stepping on thunder" on quality issues
.
In response to the problems of processing, counterfeiting, sales of counterfeit products, and irregular processing and processing in the traditional Chinese medicine decoction industry, in recent years, the country and the locality have successively issued corresponding policy management practices.
The implementation of the new version of the pharmacopoeia is even more important for the production of TCM decoction pieces.
The link puts forward strict requirements.
Under this background, decoction pieces enterprises should pay attention to the drug production quality supervision link and regulate their operations in order to go further
.
According to the list of drugs that did not meet the standard requirements for the supervision and sampling inspection, a total of 8 batches of drugs did not meet the requirements for the random inspection.
Chinese Herbal medicine involving multiple batches, comprising a non-compliant projects] [check the amount of difference, dissolution [], [] to check the amount of ethanol, Determination of content, the weight difference [], [] characters and the like
.
The 8 batches of unqualified medicines investigated and dealt with include three batches of Chinese patent medicines: Nanbao capsules, Huoxiang Zhengqi water, and Yinao tablets; three batches of Chinese medicine decoction pieces of Fritillaria vulgaris, Jigucao, and safflower, and omeprazole enteric-coated Two batches of western medicine, capsules and berberine hydrochloride tablets
.
From the point of view of the labeled manufacturers, a certain decoction piece company has failed to pass the two varieties of chicken bone grass and zhe fritillary
.
It is understood that the pharmaceutical company has repeatedly been exposed to produce substandard drugs.
Since 2018, there have been 8 batches of unqualified drugs.
On November 10 this year, the Zhejiang Fritillaria produced by the pharmaceutical company was also detected as substandard.
In addition, in January this year, the pharmaceutical company was found to have 1 serious defect, 1 major defect, and 10 general defects during the daily inspection, which did not meet the requirements of GMP (Good Manufacturing Practice).
He was warned, interviewed and ordered to make rectification within a time limit
.
Another decoction piece company has repeatedly "stepped on thunder".
Since 2018, the company has had 46 batches of drugs found to be unqualified, of which 6 batches have been convicted of counterfeit drugs
.
For these decoction pieces enterprises, under the implementation of the new version of the Drug Administration Law, the production and sales of counterfeit and inferior drugs will bear an extremely high price.
For the long-term stable development of the enterprises, it is urgent to strengthen the quality supervision of production links
.
On October 9 this year, the Zhejiang Provincial Food and Drug Administration issued the second phase of the 2021 drug quality announcement.
There were 10 batches of unqualified drugs, of which nearly half of the unqualified drugs were decoction pieces of traditional Chinese medicine
.
It can also be seen from this list that proprietary Chinese medicines and decoction pieces of Chinese medicine are still the "severe disaster areas" where medicines are unqualified
.
In addition to Zhejiang Province, looking back at this year, news about the unqualified sampling of Chinese herbal medicines also appeared in the notices of local drug administrations
.
For example, on October 29, the Yunnan Provincial Food and Drug Administration issued a 2021 Phase 3 Drug Quality Announcement
.
This time, 21 batches of drugs from 13 drug manufacturers were found to be unqualified, including 18 batches of Chinese herbal medicine pieces, which accounted for 80% of this unqualified list
.
On October 27, the Hebei Provincial Food and Drug Administration issued the 2021 Phase 3 Drug Quality Announcement.
This time, two batches of TCM decoction pieces were found to be unqualified
.
On October 18, in the drug quality announcement issued by the Chongqing Drug Administration, 4 batches of Chinese herbal medicines were unqualified, including Shouwu vine, leech, ginseng, and gastrodia superfine powder
.
The industry pointed out that the traditional Chinese medicine decoction pieces industry is developing rapidly, but the accompanying quality problems are also very prominent.
Because the decoction pieces themselves are not easy to store, and the quality control in the production process is difficult, many companies are "stepping on thunder" on quality issues
.
In response to the problems of processing, counterfeiting, sales of counterfeit products, and irregular processing and processing in the traditional Chinese medicine decoction industry, in recent years, the country and the locality have successively issued corresponding policy management practices.
The implementation of the new version of the pharmacopoeia is even more important for the production of TCM decoction pieces.
The link puts forward strict requirements.
Under this background, decoction pieces enterprises should pay attention to the drug production quality supervision link and regulate their operations in order to go further
.
