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Yangzijiang Pharmaceutical Group has always been committed to building a quality management system that is ahead of domestic GMP standards. At the beginning of the 21st century, it began to actively learn and introduce advanced quality management concepts and standards from the European Union. After several years of unremitting efforts, some of the Group's workshops are in domestic pharmaceutical companies. Take the lead through the EU GMP certification. In April 2009, when the State Food and Drug Administration's Investigation Group for Pharmaceutical GMP (Expert Revised Manuscript) visited the Yangzijiang Pharmaceutical Group, Xu Zhiren, Chairman of the Group, expressed strong support for the revision and implementation of the new GMP, and considered the implementation of the new GMP as The domestic pharmaceutical manufacturers further pointed out the direction for the development of pharmaceutical production quality management. It was a vigorous initiative of the national drug regulatory agency and hoped that the new GMP could be promulgated and implemented as soon as possible. After the new version of GMP was promulgated in January 2011, Yangzijiang Pharmaceutical Group adhered to the point and face to enlarge the GMP certification effect of the EU, and actively organized the employees of the Group to seriously study the contents of the new GMP. In accordance with the requirements of the regulations, it grabbed time and made progress, and successively invested more than 500 million yuan. Funds to carry out technological transformation of the plant hardware, fully open the road to the group's new GMP certification.
In the face of what the domestic industry has called "the strictest GMP in history," Yangzijiang Pharmaceutical Group is not taking a wait-and-see attitude but is actively fighting. In the face of the new GMP certification work, Yangzijiang Pharmaceuticals has carried out in-depth analysis and understanding of the connotations and principles of the new GMP, implemented hardware upgrades, improved the quality management system, and focused on strengthening personnel training, software revision, verification and verification, etc. The work has optimized the quality risk management system, the corrective and preventive measures management system, and so on.
In September 2011, the inspection team of Jiangsu Province Food and Drug Administration inspected the new GMP-certified cephalosporin tablets and hard capsules and anti-tumor tablets for Yangzijiang Pharmaceutical Group, from quality management, organization and personnel, plant More than 10 aspects including facilities, equipment, confirmation and verification, and document management were inspected on site. After comprehensive inspection team assessment, cephalosporin tablets and hard capsules, anti-tumor tablets meet the requirements of the new version of GMP, the first in the group to obtain a provincial-level new drug GMP certificate. In October 2011, the large-volume injections produced in the No. 3 plant of the Group's infusion passed the on-site inspection of the new GMP certification of the inspection team of the State Food and Drug Administration and obtained a national-level new drug GMP certificate. As of now, the Group's sterile powders, freeze-dried powder injections, large-volume injections, small-volume injections and other sterile dosage forms, tablets, hard capsules, granules, oral liquids, powders, creams and other non-sterile formulations and raw materials are Has passed the new GMP certification.
Fully passed the new GMP examination and entered the high threshold of drug production, marking a new level of improvement in the quality management level and product quality of Yangzijiang Pharmaceutical, ensuring the market competitiveness of the product. Chairman of the Yangzijiang Pharmaceutical Group, Xu Jingren, said, “In 2013, Yangzijiang implemented and implemented the excellent quality performance management model in the process of improving the quality management system, started the Jiangsu Provincial Quality Management Award application report, and accelerated the pace of quality management. It will also leverage on a sound quality system to accelerate the transformation and upgrading of enterprises, vigorously promote Six Sigma management, align with the US FDA, and integrate with international standards at a higher level of quality management, and actively participate in the competition of the international pharmaceutical market, aiming at the international frontier and the world. The advanced level will accelerate the international certification of the Group's pharmaceutical production and accelerate the pace of product entry into the international mainstream market!"
Yangzijiang Pharmaceutical passed the new GMP certification "exam"
On December 17, 2013, Yangzijiang Pharmaceutical Group ushered in an on-site examination of the new GMP certification for the 4th-day workshop on cephalosporin powder injection in the inspection team of the State Food and Drug Administration, and successfully passed the inspection on December 20th. At this point, the Group's 37 workshops produced formulations and APIs that fully passed the new GMP certification. Non-sterile drugs such as solid preparations and oral liquids were fully advanced two years ahead of the national certification deadline, becoming one of the few countries in the country to fully pass the new edition. GMP certified large pharmaceutical companies.