Many pharmaceutical companies in Shandong have defects in production and are ordered to be reformed.
Qilu Evening News reporter Wang Xiaomeng
19 day, the Shandong food and Drug Administration Bureau reported the results of the inspection of pharmaceutical enterprises in April. A total of 40 units were examined on the site, of which 30 enterprises, such as Shandong Hong Ji Tang Pharmaceutical Co., Ltd., had 30 enterprises and other enterprises, and 6 enterprises, such as Huayu Chinese herbal medicine beverage Co., Ltd., were in violation of the production behavior of drug GMP. Drug companies that found problems were ordered to make rectification.
sampling found that 2 enterprises such as Shandong Yi Ting Tang gelatin Group Co., Ltd. had a serious violation of drug GMP production behavior. Among them, some records of Shandong Yi Ting Tang gelatin Group Co., Ltd. are not in conformity with the regulations, and are not equipped with atomic absorption spectrophotometer. Shandong Shun Sheng Tang traditional Chinese medicine beverage Co., Ltd., the existence of partial titrant preparation and the calibration of the original record can not fully prove its authenticity, copper, arsenic element standard solution label identification is incomplete and so on.
to this, the Provincial Bureau of food and drug administration decides to recover the certificate of the standard for the quality management of drug production, and supervises the enterprise to rectify and organize the reexamination in time, and submit the rectification report and reexamination opinion to the review and Certification Center.
at the same time, Pingyi Huayu Chinese herbal medicine and Beverage Co., Shandong hundred flavor Tang Chinese herbal medicine, Yantai Lu Yin pharmaceutical industry, Weihai life medicine industry, Penglai Jin Chuan pharmaceutical industry, Linyi Li Kang traditional Chinese medicine beverage Co., Ltd. and other 6 enterprises, there are also breaches of the production behavior of drug GMP. For example, the batch production of Chinese herbal medicine in Shandong is not suitable for the production capacity, and the related records are not true and the content is not complete. The life medicine industry of Weihai has not adopted the special storage fumigation method to maintain the Chinese herbal medicine beverage according to the operating regulations. It has not taken measures to control the pollution and cross pollution, and extracts the Chinese medicine for the processing post. Green leaf (batch No. Z170301Q08) is not clean and so on.
in addition, Shandong Hong Ji Tang Pharmaceutical Co., Ltd. and other 30 enterprises, there are defects that do not meet the requirements of the drug GMP, the food and drug departments have ordered the enterprise to change the time limit. The specific problems found in the sampling inspection are as follows:
(1) Shandong Hong Ji Tang Pharmaceutical Co., Ltd. Some personnel training in the enterprise is not in place; the contents of some batch production records are incomplete; some of the original records are not accurate; the operation method of the salt water of the leek seed is not stipulated in the production process regulations of the salt leek seed.
(two) Ji'nan baud Gas Co., Ltd. The document shows that the filling amount of Lu AB0299 tanker has been deviant, and it has not been investigated and handled; all records and forms are uncontrolled; the batch number of batch number is not perfect for the batch production of YT20170466.
(three) Ji'nan JINDA Pharmaceutical Co., Ltd. Part of the personnel training of the Ministry of quality inspection is not in place; some of the reagents and test solution management are not in place; the QA personnel do not confirm and count the deviations that need to be tracked and confirmed.
(four) Dong'e Ao Dong Pharmaceutical Co., Ltd. High performance liquid chromatograph detection content is not complete, lack of maintenance records; GMP training in the training files lack of personnel signature, assessment results and other contents; individual plant facilities maintenance is not in place; normal temperature medicine library, cool crude medicine library, the information of the cargo card.