Re: many pharmaceutical companies in Shandong have defects in production and have been ordered to make rectification.
(seventeen) Shandong Ren He Tang Pharmaceutical Co., Ltd. The sampling management procedure does not conform to the relevant provisions of Annex 3 of the National Bureau's Bulletin No. thirty-second of 2014; the effect of individual post training is not ideal; the procurement, acceptance, and scrap operating procedures of the mould for production are not established; the management of documents is not standardized; and the records of some inspection are incomplete, etc.
(eighteen) Shandong Tianhua Pharmaceutical Co., Ltd. The staff of the quality inspection center are not familiar with the maintenance, maintenance and operation rules of the equipment; the preparation of Chinese medicine batch number is not detailed; the equipment is not used, the maintenance records and the status signs are not used; the production workshop is not clear and so on.
(nineteen) Shandong Ke Xin Tang Chinese Herbal Medicine Co., Ltd. The quality control personnel are unfamiliar with the control of Chinese medicinal materials and finished products; the pressure meter of acetylene gas bottle for atomic absorption spectrophotometer is not checked, and the alarm device is not installed in the tank cabinet; the variety of the sample is not consistent with the record of the sample.
(twenty) Shandong Xinyi Pharmaceutical Co., Ltd. The residual material of psychotropic drugs is not strictly implemented according to the regulations; part of the verification work is not carried out according to the plan; the D level environmental monitoring operation is not standardized; the annual quality review report of the product has the data error and so on.
(twenty-one) Shandong Lu Yao Pharmaceutical Co., Ltd. The drafting of the standard operating procedure of the purified water inspection standard was not familiar with the drafting content; the verification of the storage conditions and storage period of the non control solution, the no inspection plan, the content and the impurity analysis of the control solution; the unreasonable record of the temperature and humidity in the cool left sample; the SOP documents related to the system documents and the quality assurance documents.
(twenty-two) Heze Jianmin Chinese medicine decoction pieces Co., Ltd. The name, number and number of the weighed materials were not recorded in the record of batch production records (Jiang Banxia and batch number 170217). The walls of the drugs in the production workshop of the toxic drink production workshop were not full; the personnel training was not evaluated effectively; the maintenance records of Chinese medicinal herbs were not established.
(twenty-three) Shandong Xili Pharmaceutical Co., Ltd. Personnel training failed to carry out targeted training; internal packaging room (aluminum plastic line) drinking water pipe and wall connection is not sealed; not established high performance liquid chromatograph, infrared spectrophotometer instrument maintenance and maintenance records; in the temporary storage of medicinal plastic bottles, no cargo card and so on.