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Newly-built Anti-tumor Drug Preparation Workshop of Betta Pharmaceuticals Passing GMP Certification
Form: QC Department   Date: 2017-09-05

    The newly-built anti-tumor drug preparation workshop of Betta Pharmaceuticals has passed GMP certification recently and obtained Drug GMP Certificate issued by Zhejiang Food and Drug Administration. 


    According to Administrative Measures for Drug GMP Certification and Notification on Implementation of Administrative Measures for Drug GMP Certification (Revised in 2010) (CFDA [2011] No. 101), Drug GMP Certification is a supervision and inspection approach conducted by drug supervision and administration department on drug production quality of drug manufacturers legitimately, as well as the supervision and management process to inspect and evaluate the implementation of drug GMP by manufacturers and determine the issuance of certificate.  


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Newly-built Anti-tumor Drug Preparation Workshop of Betta Pharmaceuticals Obtaining Drug GMP Certificate 


    The construction of tablet preparation workshop (anti-tumor drugs) located at the new headquarters of Betta Pharmaceuticals was started in 2013 and the main structure was completed at the end of 2015. With the joint participation of equipment department, preparation and production department, financial department and QC department, the selection, purchasing and installation of production equipment and facilities have been completed; and the installation and debugging were basically completed in August 2016. In November 2016, the pilot production, three-batch process certification and related quality research were completed in succession, under the common efforts made by preparation and production department, equipment department and QC department. In May 2017, QC department submitted the application of Drug GMP Certification to Zhejiang Food and Drug Administration. 


    During the period between June 21st and 23rd, 2017, Zhejiang Center for Drug Inspection authorized an expert team to launch a site inspection on the aforesaid tablet workshop (anti-tumor drugs). In the on-site inspection, QC department, production center, administration department and HR department made joint efforts to complete the on-site inspection excellently and completed the follow-up rectification. 



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First Conference of Inspection for Drug GMP Certification


    On August 30th, 2017, Zhejiang Food and Drug Administration issued Drug GMP Certificate to newly-built workshop (anti-tumor drugs), No: ZJ20170058. 


    After obtaining Drug GMP Certificate for Tablets (Anti-tumor Drugs), the annual production capability of Icotinib Hydrochloride will be expanded from 25 million tablets to 60 million tablets. The remarkably enhanced production capability of Icotinib Hydrochloride tablets will satisfy the increasingly urgent market demand and play the positive role to maintain the sound operation and sustainable development of the Company. 


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