2020 Drug Quality Announcement Large Inventory

According to incomplete statistics 2020 State Bureau, provincial drug regulatory bureau quality sampling does not meet the requirements of a total of 1249 batches, including 20 batches of hospital preparations, marked production enterprises denied for their products 148 batches, non-production enterprise reasons / improper storage / retention of samples qualified, such as 41 batches, these data are not included in the statistical analysis.
the data analyzed are 1035 batches related to pharmaceutical companies, involving 562 pharmaceutical companies, 464 varieties.
Among them, 782 batches of Chinese herbal medicine/Chinese medicine tablets (involving 381 pharmaceutical companies), 116 batches of Chinese medicine (involving 80 pharmaceutical companies), 121 batches of chemical drugs (involving 86 pharmaceutical enterprises), 12 batches of pharmaceutical packages (involving 11 pharmaceutical enterprises), 2 batches of accessories, biological products, miao medicine each 1 batch.
small compilation statistics of the number of unqualified enterprises found that chemical drugs, Chinese medicine enterprises are very coincidental are 9 batches, 4 batches, 3 batches, 2 batches and 1 batch.
2020 quality sampling of Chinese chemical drugs 121 batches, involving 86 pharmaceutical companies, 68 varieties, 25 testing items.
2020 chemical drug sampling failed the top three varieties: injection of amicca (14 batches), nofluorosa star capsule (10 batches), injection of Ozagre sodium (8 batches).
the top three non-conforming tests for chemical drug sampling in 2020 were visible foreign property (23 batches), solubility (22 batches), clarity and color of the solution (16 batches).
The chart above shows the ranking of more than 3 batches (including 3 batches) The table above shows that more than 3 batches (including 3 batches) related to the variety situation II Chinese medicine 2020 quality sampling is not unqualified Chinese medicine 116 batches, involving 80 pharmaceutical companies, 75 varieties, testing items 26.
the top three non-conforming varieties of Chinese medicine were shisha night light pills (11 batches), compound dansin tablets (5 batches), and infant spleen dispersion (4 batches).
The non-conforming testing items of Chinese medicine were concentrated, followed by load difference (18 batches), weight difference (13 batches), moisture (13 batches), identification (13 batches), content determination (13 batches), characteristics (12 batches), microbial limits (12 batches).
chart above shows which varieties are involved in the nonconforming testing items in the ranking of more than 3 batches (including 3 batches)? Unqualified varieties are more dispersed; the table below shows the ranking of more than 3 batches (including 3 batches): 3 Chinese herbal medicine / Chinese medicine drink tablets 2020 sampling non-conforming Chinese herbal medicine / Chinese medicine drink tablets 782 batches, involving 381 pharmaceutical companies, 306 varieties, 38 test items.
, 14, 12, 11, 13 enterprises that failed 3 batches of sampling were selected.
The top five unqualified varieties of Chinese herbal medicine/Chinese medicine drink tablets were former Hu (26 batches), yams (16 batches), white fresh skin (14 batches), masturbation lamb (13 batches), and rice buds (12 batches).
The chart above shows the ranking of more than 6 batches (including 6 batches) the top five non-conforming test items for Chinese herbal medicine/Chinese medicine tablets are characteristics (365 batches), content determination (236 batches), identification (88 batches), total ash (62 batches), inspection (39 batches).
the chart above shows more than 9 items (including 9 items) ranking the top five varieties of test items: former Hu nonconforming (28 batches): content determination (21 batches), characteristics (5 batches), identification (2 batches).
White fresh skin is not qualified (22 batches): traits (10 batches), impurities (6 batches), total ash (2 batches), magnesium salt, aluminum salt (2 batches), inspection (1 batch), leachate (1 batch).
Yams are not qualified (22 batches): total ash (8 batches), identification (6 batches), sulfur dioxide residue (4 batches), concoced (2 batches), and nature (2 batches).
small grass failure (18 batches): the nature (9 batches), identification: (9 batches).
(15 batches): content determination (10 batches), traits (2 batches), total ash (2 batches), impurities (1 batch).
2020, a total of 12 batches of medicinal packages failed.
composite film 5 batches, ethylene bag 2 batches, medicinal compound hard tablets 2 batches, eye drops bottle 1 batch, sodium calcium bottle 1 batch, medicinal polyester bottle 1 batch.
2020 pharmaceutical accessories a total of 2 batches of non-conforming, black iron oxide and hydroxypropyl starch hollow capsules.
not increased in the second half of the year.
6 Biological Products / Miao Medicine 2020 Biological Products and Miao Medicine each 1 batch of non-conforming, pain medicine (large), recombinant human granulocytic stimulation factor injection.
is prone to non-conforming testing items Visible foreign-chemical injections 2020 chemical drug sampling non-conforming test items accounted for the first is still visible foreign property (23 batches).
As in previous years, we in the injection product inspection of all non-conforming items, it can be seen that foreign object inspection items always ranked first, because of quality problems recalled products are mostly injections and mainly chemical injections, the reasons for the recall "'visible foreign objects' do not meet the requirements" appear the most frequently.
can be seen that foreign objects indirectly reflect whether the drug is strictly in accordance with the requirements of GMP production, the product prescription, process, the choice of pharmaceutical package is reasonable, the choice of dosage form is the right.
2020 chemical drug detection solubility of a total of 22 batches.
non-sterile preparation production due to the properties of raw powder, accessories properties, process control and other reasons caused by non-conformity.
Safety Project Countries pay more and more attention to the detection of drug safety projects, has issued 96 varieties of 86 supplementary testing methods and testing items . . . 86 supplementary testing methods released, pharmaceutical people have to pay attention to! The new edition of the Pharmacopoeia adds tests for heavy metals, pesticides, aflatoxin, etc.
aflatoxin inspection is not qualified: cypress ren (3 batches), lotus, production yuanzhi each 1 batch is not qualified.
metals and harmful elements are not qualified: gold and silver flowers, hawthorns (net hawthorns) (marked raw hawthorns), a gum, otters, white slugs each 1 batch is not qualified.
pesticide residues are not qualified: ginseng, Western ginseng each 2 batches.
Sulphur dioxide is not qualified: yams (4 batches), chrysanthemums (2 batches), Gegen (2 batches);
detected gold amine o: Yuanhu painkillers (2 batches).
Detected 808 fishy red, 808 fishy red 2: Zhu sand (1 batch) identification (water wheat winter acid): ginger semi-summer (2 batches) easy counterfeit varieties Generally speaking, micro-identification is not qualified, basically represents the drink tablets are "fake medicine", from the unqualified catalog can also be seen, often micro-out of line varieties, often accompanied by sex, identification, content determination.
So, the following micro-identification of unqualified varieties, in particular, we pharmaceutical people need to "open their eyes", can not let "fake drugs" out of the factory, can not let "fake drugs" into the pharmaceutical companies to invest in production.
Micro-identification of unqualified varieties: small grass (7 batches), yams (6 batches), tong grass, wheat winter, sea wind vine, Whitehead 3 batches each), mountain mushrooms, green , Gan Pine each 2 batches, western red flowers, smallpox powder, winter, dandelion, Mabo, money grass, thick, Gegen, self-defense, Buddha hand, big yellow, grass beans , white and each 1 batch is not qualified.
non-production reasons 2020 non-conformity testing project non-production enterprises reasons / improper storage / sample retention qualified, such as a total of 41 batches.
There are 22 varieties of Chinese herbal medicine and Chinese medicine tablets: Ai Ye, Bai Yi, Cypress Ren, Fried Lai zi, When return, Party ginseng, solo, windproof, melon
8 varieties of Chinese medicine: broken blood flow tablets (film clothing tablets), compound shiwei capsules, ginseng white art pills, ancient Han health tablets, psychic capsules, heart can be comfortable tablets, dragon tiger dan, silver tablets 3 varieties: nirzyme flat tablets, children ibuprofen hydrants, penicillin V potassium tablets circulation link, storage conditions affect the quality of drugs.
quality people should be paid attention to, reasonable provisions of storage, circulation link conditions, better guarantee the quality of drugs.
: 1, quality announcement information statistics time from January 1 to December 31, 2020, the announcement marked the 2020 sampling content;
2, data from the national, provincial and municipal drug regulatory bureau website published data.
3, non-conforming items by the detection of the project count, the number of items will appear greater than the number of varieties.