5 Pharmaceutical companies were punished for violating GMP

On November 30, the Liaoning Provincial Drug Administration, the Guangxi Zhuang Autonomous Region Drug Administration and the Tianjin Municipal Market Supervision and Administration Commission announced the punishment, and five pharmaceutical companies were punished for violating GMP.
1, the production of enterprise ointment quality safety risks and hidden dangers were discontinued in July 2020, Liaoning Bureau of Dandong Pharmaceutical Group Co., Ltd. carried out supervision and inspection, in the inspection process found that the enterprise's omelette production quality management system in the chinese and foreign packaging positions there are major defects, the enterprise's omelette production there are quality safety risks and hidden dangers.
In accordance with the provisions of Article 99 (3) of the Drug Administration Law of the People's Republic of China and Article 59 (1) (2) of the Measures for the Supervision and Administration of Drug Production, our Bureau has decided to suspend the production of ointments by Dandong Pharmaceutical Group Co., Ltd.
2, enterprises have packaging standard printing errors and other 4 violations of GMP behavior was punished the parties: Guangxi Liuzhou BaihuaTang Chinese medicine tablet factory co., Ltd. November 25, 2020, our bureau of law enforcement officials to supervise and inspect the parties, the parties have the following behavior: 1. The parties produced Chinese medicine tablets Haixuan Leather (lot number 20200610), its quality standard is "Shanghai Chinese medicine drink tablets preparation norms" (1994 edition), the batch of Chinese medicine drink tablets finished packaging label quality standards incorrectly printed into the Guangxi Zhuang Autonomous Region Chinese medicine tablets preparation norms (2007 edition).
2. The self-test report of the finished product of Chinese medicine drinking tablets (lot number 20200610) shows that the batch of Chinese medicine drink tablets is tested in accordance with the "Guangxi Zhuang Autonomous Region Chinese medicine tablets preparation specification" (2007 edition), the inspection reviewer signed without careful review.
3. Quality authorized person has not carefully reviewed the batch of Chinese medicine drinking tablets sea oscipics (lot number 20200610) batch production records, inspection records, that is, to give approval for release.
4. The parties did not form a deviation investigation report on the misre citation of the quality standards of the Chinese medicine tablet sea oscipics (lot number 20200610).
The above-mentioned acts of the parties do not comply with the provisions of Articles 209, 223, 230 and 250 of the Code of Quality Management of Pharmaceutical Production (as amended in 2010).
party's non-production of drugs in accordance with the Code of Quality Management of Pharmaceutical Production (as amended in 2010) violates the provisions of Article 43 of the Drug Administration Law of the People's Republic of China.
In accordance with the provisions of Article 23 of the Administrative Punishment Law of the People's Republic of China and Article 126 of the Drug Administration Law of the People's Republic of China, you (units) are hedding the above-mentioned violations and shall be ordered to make the following administrative penalties: warning.
3, the enterprise has raw material storage temperature does not meet the requirements of 2 major defects and 15 general defects, was punished the parties: Tianjin Kaiyu Pharmaceutical Co., Ltd. October 20-21, 2020, our bureau of Tianjin Kaixuan Pharmaceutical Co., Ltd. inspection.
inspection process found that the enterprise has raw material storage temperature does not meet the requirements of 2 major defects and enterprises in 2020 in accordance with the prescribed training plan to carry out training and other 15 general defects.
illegal facts: After investigation, "Tianjin Chinese medicine drink tablets preparation norms" (2018 edition) under the Wu chicken powder, storage conditions for refrigeration.
in the course of the inspection on October 20-21, 2020, it was found that three boxes of black chicken powder with the batch number was stored in the shady warehouse, and during the on-site inspection on October 27, 2020, three boxes of black chicken powder with the batch number was still stored in the shady storage space.
party storage area can not meet the storage conditions of material products (such as temperature and humidity, avoiding light) requirements.
Stevia (1kg per bag) in use for the whole bag to the workshop, in the workshop for each batch weighing, each batch weighing, recorded in the "staging room material ledger", after multiple batches of weighing will open a picking list, such as g, sent to the warehouse, the warehouse will be in the "original auxiliary package location card" registration.
records in the "Staging Room Material Account" correspond to a record on the "original auxiliary package location card", and the time cannot correspond one by one.
this behavior is likely to cause confusion and errors in the process of receiving, storing, disansocing, using and shipping materials.
parties in the 2020 Training Plan form for April integrated treasury management documents training plan, due to the outbreak did not go ahead as planned training, the parties plan to postpone the training.
During the inspection on October 20-21, 2020, it was found that the finished oral liquid of the blood-raising blood of Wuji guiyuan, with the batch number, was stored in a room at room temperature outside the shady warehouse and was not stored in the shady storage room in accordance with the storage conditions of the finished product.
After investigation, the four batches of finished products are ready for sale issued, but due to the dealer's reasons temporarily failed to issue, shady storage has no place to store, so placed in the room at room temperature, the four batches of finished parties have been re-inspected on October 22, 2020, the test results are in line with the provisions.
the area of the finished product shady storage does not match the production scale, and there is not enough space to store the finished product produced by the party concerned.
package library found 1460 batch, 14,000 batch box and 29 batch, 9 batch packaging box are non-conforming pharmaceutical packaging materials, the parties plan to destroy in early October 2020.
the above unqualified drug packaging materials pulled out of the non-conforming area, due to temporary other work arrangements, could not be destroyed in a timely manner.
parties failed to store the non-conforming drug packaging materials in isolation and storage that could not be destroyed in time.
Law enforcement personnel in the workshop filling room found the placement of equipment number 032101-03 oral liquid filling machine 1 and L-type transmission track, operators in the upper cover operation need to be drilled from the transmission track, not easy to produce operation, filling machine rolling cover positioning module rust.
law enforcement officials in the workshop distribution room found the storage model HQ-B500 x 500 x 24 stainless steel plate frame multi-layer filter 1, in stainless steel plate frame multi-layer filter at the top of the hydraulic cylinder there is rust.
the relevant equipment of the parties is not easy to operate, and the relevant equipment is rusty.
the table scale used for the weighing of accessories in the actual use of the process, respectively, using 1g of weight and 1000g of weight, placed on the scale, record the measurement value, and fill in the verification record.
accessories actually use up to 600g, in October 20-21, 2020 inspection process, the parties employees think that is only a demonstration of the verification process, put 500g weight on the scale and read, the employee did not know that should be in accordance with the actual situation.
range of the calibration of the table scale used by the parties for the weighing of the accessories may cover the scope of actual production use.
scales stored in the weighing chamber (No. F032002) are not marked with an identification indicating the validity of the calibration.
Upon enquiry, the employees of the parties removed the calibration mark and did not paste the new logo in time when cleaning the electronic scale number F032002, which was calibrated on December 17, 2019 by Standard Technical Services (Tianjin) Co., Ltd., with a recommended re-correction period of 12 months in the calibration certificate.
party that the scale is calibrated and within the validity period, but the scale does not indicate the validity period of its calibration.
The parties in the production of the use of large shoals, but the Chinese pharmacopeia only the original herbs, inspection records in accordance with the actual shoals of the nature of the tablets for the tablets, quality standards in accordance with the Chinese pharmacopeia for the nature of the round.
, there is a situation in which the original records of the inspection of the Otsan are inconsistent with the features in the Quality Standards and Standard Operating Procedures of Otsan.
There are two batches of black chicken powder stored in the raw material bank freezer, the batch of 7 boxes and the batch of 25 boxes mixed in the raw material bank of 2 freezers and drinks shady storage, the freezer meets the conditions for refrigeration storage, each freezer can hold up to 16 boxes of black chicken powder, so there is a freezer is two batches of black chicken powder mixed, the middle of the cardboard was isolated.
parties did not carry out orderly batch storage of Wuji powder.
The parties asked the equipment manufacturers to water bath-type ampoule detection leak sterilization cabinet for equipment confirmation, equipment confirmation of 16 points of T3 points in the equipment's own 2 temperature probe middle position, can play a representative role, but the temperature probe in the outer line of the box can not be covered in the confirmation.
equipment confirmation in accordance with the Chinese pharmacopeia general rules under the requirements of the joint agent must not be less than 10 ml operation, and later inspection inspectors proposed that the amount should be fixed on-line, so in the process procedures to modify, the loading range of 10.2 ml - 10.5 ml, but did not re-confirm the equipment loading capacity of the oral liquid pouring mill.
each filling nozzle is sampled during normal production, but the filling nozzle is not sampled separately in the previous equipment confirmation report.
The parties in the water bath ampoule detection leak sterilization cabinet equipment confirmation failed to cover the outside line of the box temperature probe position, changed the loading range after the oral liquid pouring mill did not re-confirm the equipment loading and the equipment confirmation report did not sample the filling nozzle separately.
The location of the water pick-up and concentration process in the production record of the oral liquid batch of the party's Uji gui yuan was not separately designed to record the date, and the oral liquid of the batch number of the uji gui round blood-raising in the production process was carried out in one day, only on the date of the weighing operation record.
extraction tank (No. 031101, 031102), single-acting evaporator (No. 031201) of the "Equipment Use Record" party has been lost, has now opened the deviation investigation.
reviewer forgot to fill in the portion of the batch record with the gross repetition core.
the product in the production process, generally out of 8 barrels of dip paste, the previous process will be pre-called 8 barrels of leather weight, but when the approval of 7 barrels, when the operator forgot to modify the transfer order.
Operator ended the operation at 8:45 on July 31, 2020 after 48 hours of refrigeration, and zhang Lanfen, the operator of the next recovery of ethanol, wrote the wrong time in the operation, which should have been after 8:45.
the start and end dates of some operations are not recorded in the batch production records of the parties, the relevant equipment usage records are lost, the reviewer has not filled in the review contents, and some operations operator time records are incorrect.
the relevant contents of the Drug Quality Assurance Agreement signed by the parties and the Power of Attorney of the Legal Person of the Company have not been filled in.
key elements of the quality assurance agreement of the parties are not filled in.
the drug alert work of the parties concerned is the responsibility of the Ministry of Quality, there is no separate drug alert department, so it is not listed separately in the organization chart.
The procedures for reporting and monitoring adverse drug reactions formulated by the parties do not contain the procedures for updating instructions, document retrieval procedures, handling medical consultation and complaints, and the Regulations on the Reporting and Monitoring of Adverse Drug Reactions do not describe the specific work of the person in charge and full-time personnel for monitoring adverse drug reactions, and the contents of drug adverse reaction monitoring are not covered by the internal audit of the quality management system.
parties have not set up a specialized agency to develop a complete drug adverse reaction report and monitoring management system to carry out drug alert work.
law enforcement officials on October 27, 2020 on-site inspection of the 2nd floor of the treasury room 210 room drinks shady library found that the batch number is the batch number, the batch number is the big dragonfly, the batch number is the dragon's eye meat has been pasted sampling logo.
The party QA is responsible for the sampling of the above 3 varieties of drinking tablets, sampling day because of the need to send foreign inspection, go to the warehouse when more anxious, did not take sampling evidence, with a pen on the packaging wrote "sampled" the words, ready to come back to make up, but after coming back there are other work forget to make up the sampling logo.
party has not pasted the sampling identification for the sampled item.
parties in July 2020 with Ali Health signed the "code rest assured" traceability platform service agreement and carried out the establishment of the first and second code, electronic supervision code equipment has not yet been debugged, traceability management system has not been established.
In summary, the storage area of the parties can not meet the storage conditions (e.g. temperature and humidity, avoiding light) of the material products, in the material reception, storage, distribution, use and shipment process easily cause confusion and errors, not according to the established training plan for the corresponding training work, the finished shady storage area does not match the scale of production, not enough space to store its production of finished products, not the failure to destroy in a timely manner of non-conforming pharmaceutical packaging materials for isolation and storage, related equipment installation is not easy to operate, And the relevant equipment rust, electronic scales (No. F032002) did not indicate the validity period of its calibration, the parties have the "Otsin inspection original record" and "Dagi quality standards and standard operating procedures" in the character of the situation, the parties did not carry out an orderly batch storage of Uji powder, the parties have water bath ampoule leakage cabinet equipment confirmation failed to cover the temperature probe position in the outer tube of the box, After changing the loading range, the equipment loading of the oral liquid pouring mill was not reconfirmed and the filling nozzle was not sampled separately in the equipment confirmation report; the start and end dates of some processes were not recorded in the batch production records of the parties, the relevant equipment usage records were lost, the reviewer did not fill in the review content, and some process operators in production recorded errors; The key contents of the quality assurance agreement of The party concerned has not set up a special agency to formulate a complete drug adverse reaction report and monitoring management system to carry out drug alert work, and the party's failure to paste the sampling mark on the sampled material violates Article 18 of Appendix 9 of the Code of Quality Management of Pharmaceutical Production.
" provisions.
The basis and content of punishment: The party's storage area can not meet the storage conditions of material products (such as temperature and humidity, avoiding light) in violation of article 58 of the Code of Quality Management of Pharmaceutical Production", "The design and construction of the storage area shall ensure good storage conditions, and ventilation and lighting facilities."
storage area should be able to meet the storage conditions of materials or products (e.g. temperature and humidity, light avoidance) and safe storage requirements, and carry out inspection and monitoring.
" provisions.
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