Hubei Nokete Pharmaceutical Co.,Ltd., located at Xiaochang County, Hubei Province, China, is unique pharmaceutical company of Ginkgo Dry Extract (acetone extraction methods) in China and has obtained CEP of Ginkgo Dry Extract granted by EDQM. The CEP is valid on Jan. 09, 2019.

n  Project coordination and management

n  Documentation

n  Qualification and validation concepts and VMP

n  URS and Risk assessment

n  Design Qualification (DQ)

n  Installation Qualification (IQ)

n  Operational Qualification (OQ)

n  Performance Qualification (PQ)

n  Qualification reports-approval

n  Validation

n  Training

n  CEP preparation, submission and coordination

n  Inspection Assistance

Ginkgo Dry Extract GMP and CEP project of Hubei Nokete Pharmaceutical Co.,Ltd. was initiated on Aug. 03, 2016, CEP dossier of Ginkgo Dry Extract was submitted to EDQM via CESP on Dec. 08, 2017, and finally CEP of Ginkgo Dry Extract （Acetone extraction methods）was granted by EDQM on Jan. 09, 2019.

From Aug. 2016 to May 2017, main GMP and CEP experts of Foshan RuiTong Consulting Co.,Ltd. stayed on site and provided GMP and CEP services to Hubei Nokete Pharmaceutical Co.,Ltd.. During project, current main international regulatory guidelines were referred, such as EU GMP, US cGMP, ICH guidelines, ISO14644, etc.

Congratulations to Hubei Nokete Pharmaceutical Co.,Ltd. for obtaining CEP granted by EDQM and Thanks all members of Hubei Nokete Pharmaceutical Co.,Ltd. for sincere cooperation during project. If you need to learn more GMP and registration (CEP/DMF/ASMF/PQ) services of us, 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