国产真实乱对白精彩_CHINA四川少妇VIDEOS_久久久久久午夜成人影院_国产高清在线男人的天堂

現代中藥集團有限公司

2016年度藥品檢查報告

發表時間:2020-02-27 00:00來源:國家食品藥品監督管理總局

 II. Main findings

  A total of 220 deficiencies were identified, including 23 major deficiencies and 197 general deficiencies. There were 41 deficiencies in Quality Control and Quality Assurance, 32 deficiencies in Documentation Management, 24 deficiencies in Institutions and Personnel, 23 deficiencies in Equipment and 21 deficiencies in Verification and Qualification. The distribution was basically consistent with that in 2015.

The two manufacturers of in vitro diagnostic reagents receiving certification inspection all failed this year. The main problems were as follows:

(I) Quality Management System. Quality management system could not be effective operated and failed to meet the production and quality requirements of the products; The personnel mobility was frequent, there lacked professionals and the training was not conducted, which could not meet the quality management requirements in routine production; The operability of the documents were poor and data were incompletely recorded; relevant changes were not subject to change control in accordance with change procedure.

(II) Verification and Qualification. The enterprises failed to conduct process validation for all the products under application for GMP certification, and the cleaning validation for public equipment and facilities was not in place; part of validation records was incomplete; and some re-validation work was not conducted as required.

Part III Pharmaceutical GMP Follow-up Inspection

  I. Overview of Inspections

  In 2016, it was planned in the Announcement to conduct follow-up inspection on 215 enterprises, a total of 228 inspections. Among them, 58 inspections were conducted on the enterprises out of production or having no production for a long time, and other 170 inspections have all been conducted.

In addition, follow-up inspection was conducted on 21 sterile drug manufacturers passing provincial certification, and double random inspection was conducted on 13 enterprises. A total of 204 follow-up inspections were completed.


  12 enterprises failed in follow-up inspection, accounting for 5.9%, and 58 enterprises were issued with Warning Letter, accounting for 28.9%.

Among 12 enterprises failing in the inspection, there were 5 enterprises unqualified in casual inspection in 2015, 4 enterprises subject to double random inspection, 2 manufacturers of citicoline sodium injection and 1 manufacturer of ossotide injection. (All issues found in inspection have been dealt in accordance with the law.)

(I) The situation of casual inspection of the varieties in quality report in 2015

10 enterprises accepted the follow-up inspection on such dosage forms and varieties as eye drops, bendazol tablets and APIs of sodium benzoate, of which 5 enterprises failed, accounting for 50%, and 4 enterprises were issued with Warning Letter.

(II) Double random inspection

In order to implement the requirements of innovating the supervision inwards and afterwards by the State Council, in accordance with the unified arrangement by CFDA, double random inspection system for pharmaceuticals was initially operated in December 2016, follow-up inspection was conducted on the 13 selected enterprises. The inspections distributed in 9 provinces and involved 3 chemicals, 2 APIs and 8 TCMs. 4 enterprises failed in the inspection, and the pass rate was only 69%. In addition, 3 enterprises were issued with Warning Letter.

(III) Vaccine manufacturers

38 vaccine manufacturers that have obtained GMP certificate were marketed in the follow-up inspection plan in 2016. Except for 1 enterprise having production license and GMP certificate revoked in 2014 and 1 enterprise failing to get GMP certification in 2015 due to the application for the change of production address, the follow-up inspection was conducted on other 36 vaccine manufacturers. All 36 enterprises passed the inspection, and 7 enterprises which found general risks and can be improved by rectification were issued with Warning Letter. According to experts assessment that one critical deficiency that was evaluated by inspectors on site should be decreased to major deficiency, being low risk. On the whole, the quality risks in vaccine production are controllable and the manufacturers have a standardized production and quality management.

(IV) Blood product manufacturers

26 blood product manufacturers were marketed in the follow-up inspection plan in 2016. Except for 1 enterprise in production suspension and rectification, the follow-up inspection was conducted on other 25 blood product manufacturers. All 25 enterprises passed the inspection, and 4 enterprises which found general risks and can be improved by rectification were issued with Warning Letter. On the whole, the quality risks in blood product production are controllable, the manufacturers have a standardized production and quality management, but the supervision shall be intensified for individual enterprises.

(V) The manufacturers issued with warning letter in 2015

Follow-up inspection has been conducted on 32 manufacturers issued with warning letter in 2015. The manufacturers were basically met the requirements, but 14 manufacturers were issued with warning letter again.

(VI) The situation of casual inspections on the sterile drug manufacturers passing provincial certification after the decentralization of certification

21 sterile drug manufacturers passing provincial certification received casual inspection. All of them passed the inspection and 6 enterprises were issued with Warning Letter. According to the inspection result, the Provincial Bureau can undertake the GMP certification inspection functions smoothly down.

(VII) Special inspection on high-risk varieties

This year, follow-up inspection was mainly conducted on the injection of three products including ossotide, fructose diphosphate and citicoline sodium. It was planned to conduct 114 special inspections on high-risk varieties. 47 enterprises were not inspected because of failing in GMP (2010 version) certification, out of production for a long time and transfer of approval number, and 67 inspections were actually conducted. In the inspections, 1 ossotide injection manufacturer and 2 citicoline sodium injection manufacturers failed, and 21 manufacturers were issued with Warning Letter.



上一頁
...
7 8 9 10 11
...
下一頁
現代中藥集團有限公司
Copyright - 現代中藥集團有限公司All Rights Reserved.
人力資源