Re: many pharmaceutical companies in Shandong have defects in production and have been ordered to make rectification.
(six) Qingdao Tadong Pharmaceutical Co., Ltd. The enterprise has not properly maintained the individual plant; the enterprise has not established the internal control standards for the regular inspection and control of the quality of the raw water; it has not established the cleaning, maintenance and maintenance procedures and records of the operation of the equipment.
(seven) Weifang Tianyang Pharmaceutical Co., Ltd. In 2016, the enterprise produced 3 varieties, only the continuous stability inspection of the strong loquat dew was carried out; the training of individual posts was not in place; there was no clean regulation for the water tank in the water making room, and the original water tank was not cleaned and treated.
(eight) Zibo Tianyuan Biotechnology Co., Ltd. The standard weight of 5Kg in the extraction area was uncalibrated and non calibrated; the inlet and outlet pipes of the air conditioning system were not clearly identified; the number of samples of the medicinal sterile aluminum foil was not recorded in the storage card of the raw material base.
(nine) Yantai Bohai Pharmaceutical Group Co., Ltd. Part of the personnel training is not in place; the pressure difference between the outsourced workshop and the clean area capsule of the solid preparation workshop is less than 10Pa, and the high efficient coating machine and electric heating in the solid preparation workshop are not thoroughly cleaned and so on.
(ten) Zibo Huarui aluminum plastic packaging material Co., Ltd. The new purchase of aluminum foil (batch number: 17041303) in the raw material base has been posted, but no sampling sign and sample sample have been found; the product package records are not recorded in time, not in accordance with the actual operation conditions; the management of the raw material base is not in place.
(eleven) Shandong Kong Sheng Tang Pharmaceutical Co., Ltd. The information of the training records in 2017 was incomplete; the temperature and humidity control equipment had not been installed in the cold stay room; the clean area of the oral solid workshop was not clean; some inspection operations were not carried out according to the operating procedures.
(twelve) Qufu Saint Ren Pharmaceutical Co., Ltd. In 2016, the information of the annual training records is incomplete; the management of the raw material base is not standardized; the use of some experimental instruments is missing; the stevia leaf library lacks the cargo card and the material quality status logo; some facilities and equipment are not marked.
(thirteen) Shandong Jia Tai Chinese Herbal Medicine Co., Ltd. The enterprise did not appoint the sampling person through the official documents; the quality documents were not updated and revised in time; the record of the product warehouse card was not standardized; the electronic balance between the toxic pieces of the production workshop was not recorded, the standard weight and the daily calibration records of the QC laboratory balance were not recorded.
(fourteen) Shandong Sheng Xin Industrial Co., Ltd. The personnel training files were not established; the raw material suppliers were not evaluated in time; the contents of the batch production records were incomplete; the management system of purchase, storage, distribution and use of materials used for the production of drug package materials was not specified.
(fifteen) Tai'an Dongyue Gas Co., Ltd. medical oxygen branch. Lack of ventilation facilities at the production site; the company has not yet made the 2017 annual training plan; some of the QC laboratory's glass containers are already expired.