Medical network - on February 24, on February 23, the CFDA website have released the administration about 23 Chinese medicine yinpian batch unqualified notice "" children of tianjin pharmaceutical co., LTD. Tracking check the bulletin for the colorful days in hubei pharmaceutical co., LTD. Flight check bulletin.
Among them, the drug inspection offices in guangdong province, identified as hainan life of nanshan 22 companies such as ginseng industry co., LTD. 23 batch production of Chinese medicine yinpian, the relevant provinces, autonomous regions and municipalities directly under the food and drug administration has taken seized seized control measures, such as requiring companies to suspend sales use, recalls, and rectification. The CFDA designated production enterprise is located provinces (autonomous regions and municipalities) food and drug administration for the illegal behavior to carry on the investigation of the enterprise;
Tianjin children pharmaceutical co., LTD., in violation of the pharmaceutical administration law of the People's Republic of China and related regulation of drug GMP CFDA requirements and quality supervision and management committee of tianjin market to recover the business related "medicine GMP certificate", supervision and relevant product recall, and the violation behavior to carry out the investigation;
Colorful days in hubei pharmaceutical co., LTD., in violation of the pharmaceutical administration law of the People's Republic of China and related regulation of drug GMP related "medicine GMP certificate" have been repossessed, CFDA require further supervision enterprises in hubei province food and drug supervision bureau relevant product recall, conduct investigation of alleged violation in production for enterprise.
The following for details:
23 Chinese medicine yinpian unqualified batch
The drug inspection offices in guangdong province,
Labeled hainan nanshan ginseng industry co., LTD., its LeRenTang hebei pharmaceutical co., LTD., anhui Wan Sheng Chinese medicine yinpian co., LTD., anhui preplex Chinese medicine yinpian technology co., LTD., bozhou city, Chinese medicine yinpian factory, guangxi guigang shennong pharmaceutical co., LTD., the zhongke Aaron medicine trade co., LTD., and other enterprises production 13 batches of dodder unqualified;
Labeled source and anhui hall pharmaceutical co., LTD., guangxi Zhang Yitang Chinese medicine yinpian co., LTD., jiangxi # ajay national medicine yinpian co., LTD., chongqing and chongqing hall pharmaceutical co., LTD., sichuan xin kang Chinese medicine yinpian co., LTD., liangshan xin new Chinese medicine yinpian co., LTD., guizhou darling pharmaceutical co., LTD., yunnan to xinhui pharmaceutical co., LTD., kunming authentic Chinese medicine yinpian factory production of 10 batches of dodder dodder (salt) is not qualified.
Unqualified project including character, identification and content determination, and check under acid insoluble ash content, total ash, etc.
23 batch is not qualified Chinese medicine yinpian list
Note: drugs for label production enterprises marked impression deny for the enterprise production.
Unqualified to the Chinese medicine yinpian, the relevant provinces, autonomous regions and municipalities directly under the food and drug administration has taken seized seized control measures, such as requiring companies to suspend sales use, recalls, and rectification.
Administration of state food and drug supervision and administration of designated production enterprise is located provinces (autonomous regions and municipalities) food and drug administration of the enterprise on the basis of the pharmaceutical administration law of the People's Republic of China article seventy-four, seventy-four, seventy-five, the rules of production and sales of unqualified products such as illegal behavior to carry on the investigation, the punishment decision within one month, will be the penalty report administration and to the public. All the punishment shall be punishment to those responsible.
In investigation work, enterprises have objections to the authenticity of the product, can to the local provincial (autonomous regions and municipalities) food and drug administration, the local provinces, autonomous regions and municipalities directly under the food and drug administration to the enterprise production sales situation investigation, verification and would be sampling unit is located on the provinces (autonomous regions and municipalities) food and drug administration. By sampling unit seat provinces (autonomous regions and municipalities) food and drug administration received unqualified product authenticity of dissent after the notification, to initiate an investigation immediately, traces the source of products. If it is labeled production enterprise production, by the relevant provinces, autonomous regions and municipalities directly under the food and drug administration to the production enterprise shall be given a heavier punishment.
Track inspection report of tianjin children pharmaceutical co., LTD
Inspection found that the problem
A, cefaclor granules exist quality risks.
1. In September 2015, meijiang district, meizhou city, guangdong province food and drug administration found that the enterprise market sampling cefaclor particle content of 20140602 batches of unqualified, the enterprise in the investigation under the condition of insufficient or infer the unqualified reason of improper storage in circulation. Shanwei cities of guangdong province food and drug inspection offices in November 2015 and found that 20140307 of content, acidity, dissolution is unqualified, enterprise claimed that the relevant records and information has been of tianjin binhai new area market and administration of quality supervision, transferred, the scene is not available.
2. Cefaclor granules (0.25 g, batch number: 20150501) for stability test 9 months time point content test results was 89.57%, below the quality standard (90.0% 110.0%), the enterprise not to carry out the investigation. Companies said the batch of products for 12 months, 18 months content test results conform to the regulations, 91.8%, 92.07% respectively. In January 2017, submit corrective material shows firms think this batch of products pose a safety hazard, decided to recall.
Second, the source of the material and the quality control risk.
1. Enterprise cefaclor quality standards and inspection procedures of the provisions of the relevant material items in ask for "the sum of the peak area of any single impurity peak may not be over 1.8%", is not in conformity with the "Chinese pharmacopoeia" (2015 edition) paragraph cefaclor related substances of "individual impurity peak area shall not be greater than 0.5% of the main peak area of reference solution, area of each impurity peak and shall not be greater than 2.0% of the area of the main reference solution".
2. Key API into the factory inspection lax, supplier audit work there is a big deviation.
(1) YL - 44-1607006 batch of cefaclor a 10 barrels of replenish onr's stock, not according to the enterprise standard operating procedures of raw material sampling "regulation, sampling should take 4 barrels, actually only take 1 barrel.
(2) the key API cefaclor for dealers only on-site audit, not according to GMP requirements of producers he Limited audit. In cefaclor granules part batches sampling found unqualified products market, and the check specifically the presence of the defect, corrective actions have not plan to cefaclor supplier on-site audit.
Three, some production equipment after use clean incomplete, the scene found a powder residue, risk of contamination and cross-contamination. Such as appliance store rooms material transfer hoses, pressure tank, etc.
Four, in July 2016, cefaclor granules (0.125 g) specifications of weight loss increased from 1% to 1%, inventory changed from 101% to 103%, did not implement the change control procedures. Explanation for YL - 44-1607006 batch of cefaclor sieving size changes in raw material loss increase, so the increase inventory, but corrective actions is not enough, did not consider to strengthen the quality control of raw materials for cefaclor.
Treatment measures
Tianjin children pharmaceutical co., LTD. Has violated the above behavior of the "drugadministration law of the People's Republic of China" and drug GMP regulations, administration of the state food and drug supervision and administration requirements and quality supervision and management committee of tianjin market to recover the business related "medicine GMP certificate", supervision of enterprises related products recall, illegal activities of the enterprise to carry out the investigation.
The colorful days in hubei pharmaceutical co., LTD. Flight check
Inspection found that the problem
A, not through GMP certification workshop production of glue and syrups related varieties, glue varieties listed sales, and change, to paraphrase production batch number.
1, the enterprise began in July 2016, converted within the old workshop for the west side and insourcing and outsourcing west moved to the new workshop equipment, enterprises reported on September 10, 2016 west end production workshop, the new workshop and transformation of old workshop has passed GMP certification.
Site inspection found when the enterprise new rebuilt before the glue processing, extraction workshop, boiling glue, gel process, such as the ongoing production, product batch number, 1612311, 1701011, 1701021, 1701031, 1701021, 1701051, 1701061, 1701071, 1701081, 1701091, 1701081. In the newly built workshop have been found in a utility room on the second floor of a raw materials into the factory "general ledger", according to the records of paper company in October 2016 after is still on glue production.
2, ask for some production staff, have acknowledged in addition to the process validation batch products, the company also produced a strong d p syrup in new workshop 24 batch, donkey-hide gelatin, 32, antler glue 21 batch, tortoise-shell glue 13, the batch products are batch production records and batch inspection records is not available. HPLC test researchers admit that in addition to the three batch of donkey-hide gelatin of process validation, 3 batch of antler glue and inspected 3 batches of tortoise-shell glue, the other 66 batches glue product not tested (thick d phosphorus syrup does not need a high performance liquid inspection), glue is recorded in the finished product sampling and no related record of batch product sampling. Company lab technicians readme, the inspection of thick d p syrup but no record.
3, the company will be the 66 batches of untested glue products to paraphrase from the factory before the batch number of the product production sales, specific to batch number for gelatin: 1501031, 1604261, 1605151. Antler glue: 1605071, 1605091, 1605291, 1605091; Tortoise-shell glue: 1602161, 1603061, 1605011. By asking for some production staff, all admit that 66 batches glue product to use the behavior of production batches, decide the choice of batch number for workshop, products have been batch number, to avoid checking, batch production records, packaging material recipients records and storing records were not complete.
In the new workshop production 24 batches of thick d p syrup no sales; To paraphrase batch number 66 batches of glue products from the factory has some sales, in part, stored in gel, gel, drying glue and staging. Because the company did not fill in the batch production records and storage parameter, unable to accurately check form batch products to weight and distribution, and the sales staff to the company, the company confirmed, about 45000 kilograms of paraphrasing batch glue factory product sales.
Between 4, on the second floor glue workshop material found a small amount of recycling of donkey-hide gelatin, tortoise-shell glue, antler glue and other products, including a box of batches of 1409061 recycling antler glue also comes with a price of 798 yuan of retail tag on the package, by asking for glue workshop packaging personnel, confirmation will be one batch of donkey-hide gelatin, two group of tortoise-shell glue, 4 batch antler glue a total of 7 return product recycling, packaging in the new workshop, and change the drug batch number.
Second, in response to the supervision and inspection, the enterprise to set up three sets of accounts.
1, on-site inspection, quashing enterprise classification parameter in the process of the traditional Chinese medicinal materials in its archives found two this parameter west "classification of Chinese medicinal materials" (January 2016 to June), respectively, with a pencil mark flight inspection with GMP, on inquiring library staff, admitted that companies to avoid check the establishment of the three sets of accounts, as the third set of batch production records should be relatively, warehousing department established three sets of accounts. Then, from the office provides a third parameter classification of Chinese medicinal materials "west end" (January 2016 to June), without any mark.
2, in a filing cabinet to store the ledger found two this batch production order west, instruction time between January 2016 and June, respectively, in March 2016 to June.
(1) two this directive with the batch number of product inventory is not consistent. Such as: tortoise-shell glue (batch number: 1603061), tortoise shell feeding a record of 1500 kg, the other is 1000 kg; Gelatin (batch number: 1604251), charge a donkey skin is 3000 kg, the other is 2000 kg.
(2) the two instructions in one of the batch number more than another book, such as: "the west batch production order" (March 2016 to June) of donkey-hide gelatin (batch number: 1603251), antler glue (batch number: 1603291, 1604231), tortoise-shell glue (batch number: 1603311, 1604031, 1604171), in another "west batch production order" (January 2016 to June) in no related record. Production and warehouse related personnel are recognized as correspond to different record contents, the production department issued a different batch of production order.
Head finally admitted that the enterprise exists the situation of the three sets of accounts, one for real account, a set of sampling observation unqualified set up a mitigated punishment (low yield), set up a set of feedback to the market price is low (high yield). Enterprise fails to provide corresponding three sets of batch production records and batch inspection records. Check by production and warehouse personnel, have confirmed the enterprise established the three sets of records to avoid inspection.
Third, about illegal added.
1, on-site inspection on the enterprise production office found A blank paper handwritten "three gel" in recent years, the production batch, production, and into and out of the date of the intermediate station count, and in the production U disk is taken on A computer in the office to the enterprise interior is used for statistical inventory and production capacity of 2016 three rubber production record, the record details on December 18, 2015 to December 2, 2016 during the production of three rubber (donkey-hide gelatin, antler glue, glue) charge add case, of which appear many material code, such as: donkey skin A, B, C, D, P; Serve A, B, C; Tempering glue, glue sugar, old glue, etc. The record reflects the enterprise in the production of antler glue and tortoise-shell glue added a lot of (50-80%) of donkey skin D glue. Raw materials such as tortoise-shell glue (batch number: 1601061) for the donkey skin D + donkey skin P, inventory 3509.4 kg, add the tortoise shell 210 kg, tempering ash unqualified glue (batch number: 1512081) 580.6 kg; Antler glue (batch number: 1605061) the raw material for the donkey skin D (white), inventory 2987.6 kg, add antlers C (batch number: 1603291), 225 kg.
Directed against the material code and add records, inspection group to ask the production director, its recognition in the production process of antler glue and tortoise-shell glue on the different levels of add, improve yield and reduce cost in order to achieve the product conforms to the purpose of the legal standard and can avoid inspection. The donkey skin for A good quality donkey skin; General donkey donkey skin B for quality leather; Donkey skin C for the poor quality of donkey skin; Donkey skin D, 2015 years ago for mixed leather (mainly leather a variety of animal skins), USES the donkey skin, 2015 in 2016 to the camel skin; Donkey skin P for the deployment of a variety of animal skins, camel hair, donkey skin and deerskin; Moist skin for absorbing water after relatively moist skin; A deer antlers; Deer antlers and B head joint ossification content; Deer C for deerskin; Tempering rubber for molding bad or other reasons not qualified glue; Ratio of glue for camels or deerskin boil after glue; At the end of the adhesive for placed after sedimentation in the lower rubber; Chop suey skins for leather and donkey skin, small pieces of leather; Chunk of donkey-hide gelatin as the larger piece of donkey-hide gelatin, used to add use; White lace for upper antler glue white foam.
2, the company said its illegal to add behavior is due to tortoise-shell glue, antler glue not easy condensation forming. Prior to 2014, added in the tortoise-shell glue, antler glue Huang Mingjiao (oxhide gelatin) as a coagulant aid; After 2014, due to the increase in gelatin incidence detection monitoring project, in order to avoid adding Huang Mingjiao on the influence of gelatin, is changed to add gelatin, add the amount in the 30-50% range, in subsequent tortoise-shell glue, antler glue inspection standards, after adding quantity adjustment to 5%; After March 2016 to add the camel hide glue (donkey skin D), the adding amount of about 50-80%, which add the amount in the definition of around 50% for the high-end, the market price is higher, the rest are low, at the same time there are replace antlers feeding with deerskin deer (C).
Enterprises in order to leave no evidence, in purchasing payment, check incoming, in-process inspection did not keep relevant records, by asking relevant staff, confirmed the main additive donkey skin D for camels. Acceptance after confirmed by the relevant personnel weighing number put in storage, not fill in the inspection form, please, don't record material accounting, purchase department manager to fill in payment application form, by the finance manager shall be carried out in accordance with the donkey skin of payment for the payment. Record of recipients extract workshop recipients not fill in the related personnel, all at once to get the library camel feeding production, also don't fill in the corresponding production records.
Four, allegedly faking, tamper with the batch production records.
On January 10, 2017 at 9 am, inspection group flight inspections into the colorful days in hubei pharmaceutical industry, in the company on the first floor conference room, found the company relevant personnel are modify the content according to the scheduled for March 2016 strong d p syrup (lot 1603206) and the November 2015 tortoise-shell glue (lot 1512051) and batch production records, modified in tortoise shell plastic cover (lot 1512051) batch production records are "please check the date on the report should be on January 24" annotation "; Live another find in many pages of blank paper written since 2014 to modify batch production records of personnel division of labor, variety, batch number, modifications, etc.
Five, the other problems.
1, for the vision for the determination of glue content fly U3000 high performance liquid chromatograph modified by the computer system time, involved in batches for September 16, 2016 in detection of antler glue and gelatin 1606151 six years on October 13, 1604251201 detection of tortoise-shell glue and gelatin 1605011, 1604271, the main reason is found in the self-inspection process antler glue and gelatin 1604251 1606151 two batch of products have been delivery, but the content determination of map is not complete, after added by changing the system time manner.
2, antlers, tortoise shell not according to stipulations of TCM retention samples, batch number 1501191, 1501201, 1501211, the product not retention samples; Gelatin (lot 1403081) stability after inspecting sample number minus the amount remaining with actual quantity discrepancy; In 2014 "three gel" product stability inspecting neither do 24 months; Continued stability test with constant temperature and humidity air conditioning failure, when the check is not running.
Treatment measures
Colorful days in hubei pharmaceutical co., LTD. Has violated the above behavior of the "drugadministration law of the People's Republic of China" and drug GMP regulations, food and drug supervision bureau of hubei province has recovered the business related "medicine GMP certificate", the state food and drug supervision and administration bureau requires supervision relevant product recall, the bureau of hubei province to further investigation for alleged illegal manufacture actions. |
