Flight inspection notice for Shanxi Wanglong Pharmaceutical Group Co., Ltd.

Medicinesjanuary 22ndCNFX20170003namethe company name
shanxi Wanglong Pharmaceutical Group Co.,
Ltddrug production license number
sSX20160169
the social credit code(organization code
)911410108173360
0Jiang sinminquality
jia Li
shengtheof the production
of thethequality authorized person
jia Lishengproduction address
Hou ma'noonan
Industrial Park inspection date
december 12-1
3, 2016

the inspection unit the verification center of the State Administration of Food and Drug Administration
Shanxi Province Food
and Drug Administration
the cause sin
the of the of the of the of the of the of the of the of the of the use and management of the monkey head bacteria bacteria 1 Before January 2016, the bacteria used in the enterprise's monkey head mycelium were the enterprise autobiographical strains, which came from the overlord pharmaceutical industry, and Wanglong Pharmaceuticals received no germs for identification and confirmation the new edition of the Pharmacopoeia, in response to the corresponding new standards, on July 20, 2015 in China's Microbial Species Conservation Management Committee General Microbiology Center (The Institute of Microbiology of the Chinese Academy of Sciences) to buy back 3 original strains of monkey head bacteria (strains number: 5.0028, 5.0581,5.0823), the list of monkey head bacteria belongtoin, species name is consistent with the Chinese Pharmacopeia, and then carried out resuscitation, amplification, experimental culture and formal production, but the resuscitation, amplification, storage of the species are not traceable records 2 The enterprise batch production records involving the origin of the strains are recorded as The Chinese Branch 1 (5.0028), but the current use of the strains in production is not traceable number, can not be traced to the original strains - The Chinese Branch 1 (5.0028) II, monkey head gastric capsule production used in the monkey head mycelium culture is not included in the enterprise's quality assurance system 1 The company's monkey head mycelium culture workshop because it is not within the scope of drug GMP certification, so not included in the enterprise's quality assurance system, resulting in the workshop site management confusion, no perfect document management system, operating records do not have traceability, bacteria cultivation, seed selection, mycelium cultivation by the operator with experience to control 2 Batch inspection records show that three batches of mycelium (20140801, 20140901, 20140902) were produced in 2014 However, the production and technical personnel of the bacteria workshop said: from the second half of 2013 to 2015, the workshop has not arranged the production of mycelium, and enterprises can not provide the above three batches of mycelium batch production records found in the enterprise sample room 20140903, 20141001 two batches of mycelium left samples, but did not see its inspection records and production records, nor its production after the production of the relevant preparation batch production records 3 Before October 1, 2016, the company used for mycelium identification of the work of control herbs, for the enterprise mycelium workshop culture, not in accordance with the provisions of the standard standardization In October 2016, the enterprise purchased 100 monkey head mycelium control medicine from the Chinese Academy of Inspection, currently using a total of 8, of which 2 for product inspection, the control of the medicinal solution has no preparation record, no batch number or number, no expiration date, no storage according to regulations, the other 6 uses are unknown, and no flow and use records three, other Shanxi Provincial Bureau on November 15-17, 2016 to carry out a flight inspection of the company, the inspection team on-site access to monkey head mycelium (lot number 20160701) to retain samples and corresponding finished monkey head gastric capsule (lot number 20161001) to retain samples, on-site supervision enterprises to carry out acidimethyl cellulose asease activity testing, the results of monkey head fissin vitality does not meet the provisions (200 15 version of the pharmacopeia is stipulated as "not less than 150U/g", the field test results are: 56.7U/g, the enterprise batch inspection report results are: 163U/g); Treatment measures Shanxi Wanglong Pharmaceutical Group Co., Ltd have violated the "People's Republic of China Drug Administration Law" and the relevant provisions of drug GMP, the State Food and Drug Administration asked the Shanxi Provincial Food and Drug Administration to withdraw the enterprise-related varieties of capsule production scope of the "Drug GMP Certificate", in the pre-provincial bureau has carried out flight inspection to make the treatment of the basis, supervision of enterprises have been listed for sale of related products to take necessary risk control measures, the enterprise suspected of illegal production of the behavior of further investigation and treatment Release date january 17
2017