Pharmaceutical companies were reported twice: find out to fabricate batch records, change batch number!

On August 10, Jilin Provincial Drug Administration issued the "Administrative Penalty Decision" (Ji Pharmaceutical Supervision and Drug Administration Penalty No. 2020 YS1), which summarizes the main contents as follows: Tonghua Sway Pharmaceutical Co., Ltd. for 2 complaints reported to the Jilin Provincial Drug Administration Director's mailbox, reported that: the pharmaceutical company in the production of drugs in the process of a number of illegal violations.
inspection by the State Drug Administration found that, first, fabricated the approval records of Yu'an Shen tablets, gastric likang tablets and YanLi-anti-capsules, August 1 - September 14, 2018, the production director Wang XX Organization of production Department Zhang XX, extraction workshop repairman Fan XX, extraction workshop administrator Zhou XX completed 2 batches of anti-Yu'an God tablets, 1 batch of gastric Likang tablets and 1 batch of inflammatory capsules pre-treatment extraction, concentration, drying, batch mixing process.
September 11-15, 2018, Guo XX, director of the solid preparation workshop, received the above-mentioned 1 batch of gastric likang tablet dipping cream, raw powder, volatile oil and 2 batches of anti-Yu'an tablet mixed powder, assisted by Gao XX and Fan XX, after granulation, batch Mixed into 2 batches of gastric likang tablets mixed particles and 3 batches of anti-Yu'an tablets mixed actual production process by Zhou XX pre-processing extraction production process recorded in a private work diary, by Guo XX will be the preparation production process recorded on paper, not in accordance with the "drug production quality management norms" provisions of the true record in the batch production records.
From January 19, 2019 to April 1, 2019, the Production Department he XX issued batch production instructions in accordance with the material information and time provided by the head of production Wang XX, according to the release time of the extraction batch production instructions: the above two batches of anti-Yu'an tablets mixed powder pre-processing extraction batch numbers into T190101 and T190103, will use the anti-Yu'an tablets mixed medicine Powder (pre-treatment extraction batch number T190101) made of batch mixed anti-Yu'an tablet mixed particle batch number fabricated for 190203, 190204; The above gastric likang tablet pre-treatment extraction batch number is made up as T190201, the gastric likang tablet leaching paste (pre-treatment extraction batch number: T190201) is made of mixed gastric likang tablet mixed particle batch number is made up as 190301, 190302; The above-mentioned inflammatory anti-capsule mixed powder pre-treatment extraction batch number fabricated as T190302.
Combined with the actual production situation, in accordance with the process procedures to calculate the pre-processing extraction process, preparation granulation process required time and related data, organize the relevant post operators to fill in the above-mentioned drug pre-processing extraction batch production records and pre-press production records, fabricated batch production records: de-Yu'an tablets (de-Yu'an tablets) Pre-processing extraction batch number: T190101, T190103) Gastric Likang tablets (pre-processing extraction batch number: T190201) Yanli anti-capsule (pre-processing extraction batch number: T190302) pre-processing extraction batch production Record and reconcile Yu'an Shen film (lot number: 190203, 190204, 190401) gastric likang film (lot number: 190301, 190302) II, change gastric health film, The production batch number of the anti-Yu'an shen film is checked, in accordance with your unit company document "production batch number and production date preparation procedures (document number: SMP-SC-006)" stipulates: "The production date of the preparation is the batch date as the production date; With 6 digits, two indicate the production year, the middle two indicate the production month, the last two represent the production of flowing water number", the above two batches of gastric likang piece mixed particles and 3 batches of anti-Yu'an piece mixed particles real production date should be September 2018, your unit changed the gastric health tablets, de-Yu'an shen piece finished production batch number, after changing the batch number of the finished product For sale, the specific situation is: 1. Gastric Likang tablet finished batch number changed from 180901 to 190301, the production quantity is 27626 boxes, at a price of 1.65 yuan per box sales of 9600 boxes, sales amount of 15840.00 yuan, sampling 30 boxes, inventory 17996 boxes.
2. Gastric Likang piece finished batch number changed from 180902 to 190302, the number of production is 33,250 boxes, the batch of products are not sold, sampling 30 boxes, inventory 33220 boxes.
3. The finished batch number of the de-Yu'an Shen tablet was changed from 180901 to 190203, and the production quantity was 33,133 boxes, all of which were sold to Pharmaceutical Co., Ltd. at a price of 3.1 yuan per box, with a sales amount of 102712.30 yuan.
4. The batch number of the finished product of the anti-Yu'an tablet was changed from 180902 to 190204, and the production quantity was 33220 boxes, which were sold to Pharmaceutical Co., Ltd. at a price of 3.1 yuan per box, with a sales amount of 102982.00 yuan.
the total illegal income of the gastric Likang tablets produced by the Chinese government (lot number: 190301, 190302) and the settlement of the Yu'an Shen film (lot number: 190203, 190204) amounted to 221534.30 yuan, with a total value of 306139.70 yuan.
Penalty I, fabricating batch records, fabricating the solution of Yu'an Shen tablets (pre-processing extraction batch number: T190101, T190103), gastric Likang tablets (pre-processing extraction batch number: T190201), YanLi-relief capsules (Pre-processing extraction batch number: T190302) pre-processing extraction batch production records and reconciliation Ofan Shen tablets (lot numbers: 190203, 190204, 190401), gastric Likang tablets (batch: 19 0301, 190302) The act of batching production records does not conform to Article 4 of the Code of Quality Management of Pharmaceutical Production (as amended in 2010), "Enterprises shall strictly implement this Code, adhere to honesty and trustworthy, and prohibit any false and deceptive acts", and Article 171 "Each batch of products shall have corresponding batch production records, trace the production history of the batch of products and the quality-related conditions" and Article 184 "All pharmaceutical production and packaging shall be in accordance with the approved process procedures and operating procedures and have relevant records to ensure that the drug meets the prescribed quality standards." And in accordance with the requirements of drug production license and registration approval", in violation of the People's Republic of China Drug Administration Law (2015 Amendment) Article 9, paragraph 1, "Pharmaceutical production enterprises must be in accordance with the State Council Drug Supervision and Administration Department in accordance with this Law formulated in accordance with the "Drug Production Quality Management Code" provisions.
In accordance with Article 78 of the Drug Administration Law of the People's Republic of China (as amended in 2015), "Pharmaceutical manufacturers, operating enterprises, drug non-clinical safety evaluation research institutions and drug clinical trial institutions fail to implement the Drug Production Quality Management Code, the Drug Management Quality Management Code, the Drug Non-Clinical Research Quality Management Code, and the Drug Clinical Trial Quality Management Code in accordance with the provisions, Give a warning, order a correction within a time limit; if you do not make corrections within the time limit, order the suspension of production, suspension of business for rectification, and a fine of not more than 5,000 yuan and not more than 20,000 yuan; if the circumstances are serious, revoke the provisions of the Drug Production License, the Drug Business License and the Qualifications of The Drug Clinical Laboratory Institution, and order your unit to make corrections within a time limit of 30 days, and give your unit the following administrative penalties: Warning.
II, change the production batch number of your unit production of gastric likang tablets (lot number: 190301, 190302) and reconciliation Yu'an Shen tablets (lot number: 190203, 190204) in line with the People's Republic of China Drug Administration Law (20) Article 49(3) (2) (15) "If the provisions of the production lot number are not indicated or changed, the conduct of your unit shall be treated as inferior, and the conduct of your unit shall violate the provisions of Article 49 (1) of the Drug Administration Law of the People's Republic of China (amendment 2015) prohibiting the production and sale of inferior drugs".
In accordance with Article 74 of the Drug Administration Law of the People's Republic of China (as amended in 2015), "those who produce or sell inferior drugs shall confiscate the drugs and illegal gains illegally produced or sold, and shall be fined between one and three times the value of the illegal production and sale of drugs; In accordance with Article 3 (1) (1) of the Jilin Provincial Food and Drug Administration's Administrative Penalty Discretionary Benchmark II (Drug Class), "(1) If there are any of the following circumstances, and the value of the illegal production and sale of drugs is more than double the value of the fine: 2. Only in violation of article 49, paragraph 3, of the Drug Administration Law and did not find that the inferior drug has an impact on the ability and safety of the drug" provisions to be given the following administrative penalties. Confiscation of gastric Likang tablets (lot number: 190301) 17996 boxes, gastric likang tablets (lot number: 190302) 33220 boxes; Confiscation of illegal income of 221534.30 yuan; A fine of 612279.40 yuan was imposed for double the value of the illegal production of drugs.
total amount of fines and penalties: 833813.70 yuan ( pick up ginseng million to participate in the support of ginseng meta-dye angle).
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