Medical network - March 16 March 15, national food drug safety administration issued three fly inspection report, changchun life of ginseng industry of nanshan xinan medicine, yunnan, hainan, shaanxi purple light Chen dhi pharmaceutical industry was found: changes the production process, record add many problems such as fraud and irregularities.
▍ changes the production process, equipment cover surface mould
Xinan pharmaceutical administration examination revealed, changchun will not according to the legal know-how for the cortex phellodendri boiled alcohol sink after enrichment for inflammation can better production, existing fabricated extraction record behavior. Enterprise site admitted in 3 batches inflammation can be better in the direct use of cortex phellodendri powder feeding.
D production management chaos, extract workshop area groove mixing chamber mixing equipment shows on January 10th, 2017, has been clear, but the site inspection, have clear liquid residue inside the equipment, equipment cover inner surface has a large amount of powder, and has set up a mould.
▍ add, jerry
Shaanxi purple Calvin dhi pharmaceutical suspected method not according to the stipulation of "pharmacopoeia of China production qingrejiedu films. Site in January of 2014 to 2017, the company production of all seven group qingrejiedu retention samples for microscopic identification, including four batches detected obvious gardenia microscopic characteristics, the company site admit gardenia powder is added to the batch and check in (Jan. 11) during the recalls.
At the same time, the production process of spleen-invigorating pill, allegedly cut corners. Examination revealed: 209.6 kg of recipients longan meat, according to records after feeding the rest of the 82.76 kg, but the actual remaining 100 kilograms, in conformity with feeding requirements.
▍ drug firms do not produce, just packaging sales
Hainan life of nanshan ginseng industry was found to inspection and production record is not true. As drug companies, the alleged directly purchase Chinese medicine yinpian repackaging after sales. Chinese medicine yinpian dodder production processing without batch production records, provide the batch production records for subsequent added complete.
In fact, the agency was supposed to check the enterprise of Chinese medicine yinpian "weed" dyeing problem, the result unexpectedly, the scene found no stain, is found to drug companies suspected of repackaging sales problems.
Based on this, the administration said in the announcement, take back the three pharmaceutical companies GMP certificate. In addition, xinan dhi pharmaceutical pharmaceutical and shaanxi purple light Chen for changchun to initiate an investigation.
Attach a: inspection found that the problem xinan pharmaceutical (changchun)
A change, without authorization, inflammation can be better production process, make batch production records:
Not according to the legal process will cortex phellodendri boiled alcohol sink after enrichment for inflammation can better production, existing fabricated extraction record behavior. Batches this enterprise inflammation can better piece before treatment and traditional Chinese medicine and other production records are not true, fraud. Enterprise site admitted in 20150601, 20150901, 20150601 of inflammation can be better in the direct use of cortex phellodendri powder feeding.
Second, quality control, laboratory management confusion, there make inspection records:
1. The laboratory is made up the behavior of the inspection records.
(1) is not in accordance with the purchase time and quality standard of medicinal materials cortex phellodendri, make inspection records. Such as: the actual purchase of cortex phellodendri yinpian, but project record inspection records characters of cortex phellodendri medicinal materials.
(2) on September 14, 2015, GRN record cortex phellodendri, rhizoma coptidis, radix scutellariae, radix angelicae sinensis, rhizoma ligustici wallichii, such as raw material storage, but failed to complete laboratory please check list for the above mentioned five kinds of medicinal materials, inspection report, inspection records, liquid chromatograph the raw data.
(3) part of the inspection report (including: 20150801 batch of radix scutellariae, 20150709 batches of rhubarb, 2050503 batches of radix isatidis, 20150430 batches of rhizoma coptidis) on 2015, please check and test, and found that the batch raw material in the office computer laboratory inspection report are to generate and print on January 10, 2017.
(4) cortex phellodendri (20150124) content of medicinal materials inspection item of cortex phellodendri alkali, hydrochloric acid berberine hydrochloride used the records are not seen, not seen one over one hundred thousand of weighing scales related record.
2. Analytical instruments management chaos, part of the instrument is lack of use. Companies did not perform computerized system requirements in the appendix, instrument workstations are not set permissions, not hierarchical management, not regular long-distance backup and data archive, there is new data covering the phenomenon of old data, not back.
3. The business part of medicinal materials of heavy metals, pesticide residues, evaporation only entrust inspection project such as contract, content of light does not provide a test report of the project.
4. The enterprise in accordance with the provisions of sample. Such as: 20150301 group and 20150501 group of inflammation using slice, before 2016 (cortex phellodendri, radix scutellariae, etc.) are not retention samples.
3, production management confusion
D 1. Extract workshop area groove mixing chamber mixing equipment shows on January 10th, 2017, has been clear, but the site inspection, have clear liquid residue inside the equipment, equipment cover inner surface has a large amount of powder, and has set up a mould.
2. Inflammation can be rather not seen process validation data, enterprise since the implementation of the new GMP, not to carry out the process validation.
3. Pretreatment extract liquid receiving tank is only one production water, liquid transfer alcohol sink and extract the receiver only 2 stainless steel sealed barrels, and traditional Chinese medicine extraction and the scale of production does not match.
Fourth, material management confusion, there make records
1. Purchase of cortex phellodendri in financial instrument information such as quantity, purchase time, purchasing units with warehouse keeper classification number of the accounting records, inspection and use. The enterprise has not been established material over the management accounting, allegedly faking cortex phellodendri, inventory records.
2. The varieties of medicinal materials in the library many more sampling batch quarantined herbs or slices, but the card would be recorded sample quantity and time. As December 27, 2016, from bozhou city, anhui province, Chinese medicine medicinal materials company bought cortex phellodendri, radix scutellariae, rhizoma coptidis, such as not sampling, but the keeper has been in the position to fill in "sample" on the card, sampling Luo Yan. Coptis root, kusnezoff monkshood root, cortex phellodendri, radix scutellariae, etc have sampling record, but no sample trace.
3. The Chinese medicinal materials in the library on the part of the packaging did not see the origin of a product, yinpian did not see the information such as specification, batch number, no sample identification.
4. The material supplier qualification is lax, anguo city xin bo Chinese medicine yinpian yihong send Chinese medicine yinpian co., LTD. Co., LTD. And sale 2 suppliers qualification file quality assurance agreement has expired.
Five, the enterprise, quality director, production director, director, etc cannot effectively perform the duties of a pharmaceutical production management, quality management. Quality assurance manager (authorized person) and quality failed to fulfill their duties of product release and failed to exercise quality veto.
FuEr: inspection found that the problem (shaanxi purple light Chen jizhong pharmaceutical co., LTD.)
A, allegedly not according to the stipulation of "pharmacopoeia of China fashion production qingrejiedu films. Site in January of 2014 to 2017, the company production of all seven group qingrejiedu retention samples for microscopic identification, including four batches (batch number: 150124, 150547, 151007, 150547), check out the obvious gardenia microscopic characteristics, the company site admit gardenia powder is added to the batch and check in (Jan. 11) during the recalls.
Second, the material management chaos, some material issue record is missing, the relevant production activities cannot be traced.
1. The material library card shows that gypsum, honeysuckle, rhizoma anemarrhenae number respectively into the factory (14-001, 14-001, 14-001) on December 17, 2014, used in production of 150125 batches of heat-clearing and detoxifying, but there is no production enterprise claimed that this batch of products, without the qingrejiedu piece of batch production records and retention samples.
2. 141033, 150124, 150547 group qingrejiedu gardenia for production and batch production with 160459 figwort no material issue record.
3. 141033, 150124 group qingrejiedu piece did not record production in batch production records of 12 Chinese medicine yinpian or Chinese herbal medicine materials into the factory code and batch number.
4. In January of 2014 to 2017, the production of all 7 group qingrejiedu extraction process are no equipment use record.
Three, on-site inspection, it found that traditional Chinese medicine extraction workshop 816054 batch of spleen-invigorating pill extraction operation are:
1. Not according to prescribed using jujube (pitted), use without nuclear jujube for feeding, feeding the scene entities into the factory Numbers for 16-005 not to nuclear jujube.
2. 209.6 kg of recipients longan meat, according to records after feeding the rest of the 82.76 kg, but the actual remaining 100 kilograms, in conformity with feeding requirements.
Attached 3: inspection found that the problem (hainan life of nanshan ginseng industry co., LTD.)
Inspection group packages according to the market of the Chinese medicine yinpian dyeing problems of "weed", the scene for the varieties of Chinese medicinal materials procurement, production and processing, inspection focuses on the key link to check, no evidence of lemon yellow staining found at the scene of the enterprise production, but found it in the process of production and quality management of traditional Chinese medicine yinpian mainly exist the following problems:
1. The enterprise purchases of Chinese dodder, according to the stipulation of "pharmacopoeia of China quality standard and inspection record, the purchase of raw materials such as dodder herbs and retention samples not according to stipulations.
2. The batch test record is not true. Chinese medicine yinpian dodder no record sampling, inspection process, provide the batch of products on the market by sampling inspection records after added complete.
3. The batch production record is not true, the alleged direct purchase of Chinese medicine yinpian packing after sales. Chinese medicine yinpian dodder production processing without batch production records, provide the batch production records for subsequent added complete. |
