Pharmaceutical companies through GSP certification
Release time:
2020-07-22
Pharmaceutical Company Passed GSP Certification Replacement
News 6# September 5 , Jinhua Pharmaceutical Company received the "Pharmaceutical Business Quality Management Standard Certification" certificate and the "Pharmaceutical Business License" sent by Zhejiang Food and Drug Administration, marking the successful completion of the license replacement and GSP certification inspection by the pharmaceutical company.
"Drug Business Quality Management Standard Certification" certification and "Drug Business License" renewal are carried out every five years. Pharmaceutical company passed the new version of GSP certification in 2014 , which expires in 8 this year and needs to reapply for renewal certification. On the third day of work after the Spring Festival holiday, the pharmaceutical company held a special meeting to mobilize and deploy, and formulated the implementation plan for the renewal and certification of drug GSP , which involved drug procurement, storage, sales, logistics, personnel and institutional files, Computer systems, quality management and other drug operations, designated the implementation department and responsible person, and set the completion time limit. At the same time, all departments are required to carry out self-examination and rectification according to GSP management standard, and zero tolerance for violation of GSP standard. The Quality Management Department lists the internal audit checklist of the quality management system, specifies the inspection results and responsible departments one by one according to the inspection contents corresponding to the items in Article GSP , carries out simulated inspection and acceptance on various departments and links, makes rectification and improvement on the places that do not meet the requirements, and sends the replacement application report to the provincial food and drug administration at the end of February 4 . On the morning of
5 6 , the GSP inspection team composed of three experts from Jinhua Drug Certification Center conducted a comprehensive inspection of the drug management and quality management of pharmaceutical companies according to the predetermined inspection plan. The experts were satisfied with the pharmaceutical company's GSP working software and hardware management work, affirmed the pharmaceutical company's efforts in implementing the GSP specification, and also pointed out the shortcomings. The pharmaceutical company formulated a rectification plan based on the rectification opinions put forward by the inspection team, implemented the responsible department and the responsible person, and immediately reported to the Jinhua Drug Certification Center after the rectification was in place, and successfully obtained the "Drug Business Quality Management Standard Certification" certificate and the "Drug Business License". (Fan Tufa)
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