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Review and Prospect on European and American Certification Project of Luohe Chief Pharmaceutical Co., Ltd.

发布日期:2020-12-30

Luohe Chief Pharmaceutical Co., Ltd. (afterwards named as Luohe Chief) located in Luohe City, Henan Province, China, is a newly established pharmaceutical company, which is planned to manufacture APIs for antituberculosis and HIV infection. US FDA certification for 4 products and EDQM CEP certifications for 3 products were planned by Luohe Chief.

Foshan RuiTong Consulting Co.,Ltd. (afterwards named as RuiTong) is a GMP consulting and execution company located in Foshan City, Guangdong Province, China, its main service contents include GMP consulting and execution, DMF/CEP/ASMF/WHO PQ registration, Audit.

Therefore, Luohe Chief would like RuiTong to provide GMP, CEP, DMF services to Luohe Chief according to Chinese GMP, EU GMP, US cGMP requirements and drug registration regulation requirements related to EDQM CEP and US FDA DMF.

n  Project coordination and management

n  Documentation

n  URS and Risk assessment

n  Qualification of equipment and fa

cilities

n  Validation

n  Training

n  Drug Manufacturing License application

n  4 US DMF number application

n  3 EDQM CEP Certificates application

The project was initiated on May 08, 2020 and until December 30, 2020, Luohe Chief had created complete quality system by combined effort of all person of Luohe Chief and RuiTong. At present, QC laboratory and warehouses come into use, 3 clean rooms and 3 synthesis workshops were basically completed, critical equipment and facilities had been qualified. Analytical method validation, process validation and cleaning validation are planned to be initiated in January, 2021, DMFs for 4 products and CEP dossiers for 3 products are planned to be submitted before April 30, 2021. At present, analytical methods validation protocols, process validation protocols, cleaning validation protocols, DMFs and CEP dossiers are prepared.

During construction of this project, RuiTong guided Luohe Chief to identify process risks and GMP risks via risk assessment, effective actions were taken to optimize 

production process and GMP managements, and optimize process layout design and GMP plant design, “Quality by Design” was implemented through the whole project.

During construction of this project, one GMP consultant from RuiTong was designated as quality responsible person and qualified person of Luohe Chief. Therefore, the quality of project was ensured, project progress was accelerated, many production and quality management staffs from Luohe Chief were trained. From initiation of project to now, GMP consultants and validation team members were working together with Luohe Chief, both parties will continue to implement validation activities during 2021 Chinese Spring Festival based on our plan, relevant GMP consultants and validation team members will have one memorable 2021 Chinese Spring Festival in Luohe.

Highly appreciated sincere cooperation of all project team members of Luohe Chief Pharmaceutical Co.,Ltd. and Foshan RuiTong Consulting Co.,Ltd. during project. We wish all of us could achieve our same targets, and wish all project team members and friends to be safe, healthy, successful in 2021. If your need to know more about our GMP and registration (CEP/DMF/ASMF/WHO PQ) services, please do not hesitate to contact us.






Foshan RuiTong Consulting Co.,Ltd.

Room 803, Fuwei Building, Huangqi, GuangFo Road No.1, Nanhai District, Foshan City, Guangdong Province, China

Website: http://www.gdruitong.cn/

Tel.: +86-13660057841, +86-13695153512

E-mail: ruitong01@gdruitong.cn