Warmly congratulate DST Durst on reaching FDA cGMP project cooperation with well-known radiopharmaceutical pharmaceutical companies in Sichuan!
Release time:
2024-10-25
DST Durst recently signed an FDA cGMP project cooperation agreement with a well-known and established radiopharmaceutical company in Sichuan. DST Durst will intervene in the design stage to ensure the GMP compliance of enterprises from the design stage. Durst DST will be involved throughout the FDA's cGMP program to help companies successfully pass inspections.
DST Durst recently signed an FDA cGMP project cooperation agreement with a well-known and established radiopharmaceutical company in Sichuan. DST Durst will intervene in the design stage to ensure the GMP compliance of enterprises from the design stage. Durst DST will be involved throughout the FDA's cGMP program to help companies successfully pass inspections.
Because of the limitation of the property of radiopharmaceuticals, the design needs to be scientifically laid out in the design stage, especially the flow direction of personnel and articles in the workplace, the layout of source-related links, the relevant facilities of radiation safety, etc. should be designed according to the standard, and the production process including the planning and layout of source-related links should be carried out according to the process standard, therefore, radiopharmaceutical enterprises should carry out design audit in the design stage of the plant design and the team with rich experience in the production of radiopharmaceuticals, so as to ensure the compliance of the plant and facilitate the later management, reduce the later transformation and reduce the cost.
Durst has previously helped many companies to design and review radiopharmaceuticals and other aspects, and has relevant project work and practical experience.
After the design confirmation is completed, DST DST will also provide consulting services to the pharmaceutical company on the construction and improvement of the quality system, verification and confirmation, certification guidance, etc., to ensure the compliance of the enterprise so that the enterprise can meet the requirements of NMPA and FDA cGMP in the later period.
DST DST team has been serving pharmaceutical companies for a long time. It has rich consulting service experience in the whole life cycle of pharmaceutical companies from plant design, plant construction, plant equipment acceptance, quality system construction, plant, equipment and facilities confirmation and verification, process verification, production, drug marketing license, domestic and international GMP certification, etc., and has successively provided consulting services to 100 pharmaceutical companies, it has successively completed FDA certification projects such as Zhejiang Jingwei Pharmaceutical, China Resources Sanjiu, Sichuan Huiyu Pharmaceutical, Chengdu Shengnuo Bio, Southern Pharmaceutical and Taiwan Lutos.
In addition, Durst takes the mission of enabling more pharmaceutical enterprises to reach the international top quality management level, the concept of customer first, and its own specialty as its hard strength. It focuses on serving international GMP consulting work, including FDA, EU-GMP, TGA, PIC/S, QP and other certification, audit and verification and confirmation of plant, facilities and equipment, public systems, etc. It has successively provided international GMP services for Lizhu Pharmaceutical, Baiyunshan Pharmaceutical, China Resources Sanjiu, North China Pharmaceutical, Kangtai Biology, Baiji Biology, Longsha Biology, Sinopharm Zhongsheng and other enterprises, and has been recognized by customers.
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Durst (Shenzhen) Consulting Service Co., Ltd.
Contact Phone:86-18826007039
E-mail:consulting@delsalt.com
Address: C19, Building 1, Yongheyuan, Zhuangbian Community, xixiang street, Bao 'an District, Shenzhen City, Guangdong Province
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