Quzhou City's first quality and efficacy consistency evaluation of generic drugs passed the national level on-site verification

The first quality and efficacy consistency evaluation of generic drugs in Quzhou City passed the national level on-site verification, issued by Zhejiang drug administration on May 21 It shows that the inspection center of the State Drug Administration carried out on-site inspection on the quality and efficacy consistency evaluation of amoxicillin capsule of Zhejiang Jutai Pharmaceutical Co., Ltd According to the on-site inspection plan, the inspection team composed of 4 experts conducted a 5 day dynamic inspection on the development site and production site of Amoxicillin Capsules applied by Zhejiang Jutai Pharmaceutical Co., Ltd The expert group carried out a comprehensive, strict and detailed inspection on the development site and production site, involving process development, small pilot scale-up, process validation, data integrity, GMP compliance on site, reference preparation and other links The verification experts affirmed the authenticity and consistency of the work of amoxicillin capsule consistency project, and no authenticity and consistency problems or serious defects were found in the on-site verification Amoxicillin capsule of Zhejiang Jutai Pharmaceutical Co., Ltd is the first variety that has passed the national on-site verification in Quzhou City The on-site evaluation creates a good condition for the completion of the research work on schedule, which has a good leading and demonstration role in promoting the high-quality and healthy development of the pharmaceutical industry in Quzhou City This article is reprinted by yaozhi.com The copyright belongs to the original author The purpose of reprint is to transmit more information, which does not represent the view of this platform If the content of the work, copyright and other issues are involved, please contact our website message, we will delete the content in the first time.