Bert Han： Chairman and General Manager of Hebei QbD Medical Technology Co., Ltd.Vice Chairman of Cangzhou Bohai New Area Pharmaceutical Profession Association.

Lecture topic: The Observations of the Aseptic Manufacturing

Resume

He graduated from Hebei Medical University with a master's degree in pharmacy. He has nearly 20 years' experience in the R&D and quality management in NCPC, Hebei Dawn Pharmaceutical Co., Ltd and Hebei QbD Medical Technology Co., Ltd. He has served as quality director of NCPC Create  Co., Ltd (formerly the Joint Venture Company of NCPC and Aventis ) and general manager of Hebei Dawn Pharmaceutical  Co., Ltd. He presided over the establishment of NCPC Create Antineoplastic Drug Project, and took the lead in passing the new GMP certification with the quality system of the joint venture company; established Hebei Dawn Pharmaceutical Co., Ltd., and passed the EU GMP certification with zero defect for antineoplastic injections ( Lyophilized powder injection, Non-terminal sterile injection ); and organized and completed doxorubicin liposome injection based on his own technology of liposome industrialization platform, and the R&D of daunorubicin liposomes and irinotecan liposomes were carried out; The R&D of APIs and finished drugs of Sigliptin, Ligliptin, Sagliptin, Vilgliptin and Ticagrelor were completed;The R&D of APIs and finished drugs of Gefitinib, Sorafenib, Dasatinib and Imatinib were completed; The Bortezomib API, Lyophilized powder injection and  Paclitaxel for injection(Albumin Bound) were completed; STG-175, a cyclophilic inhibitor, new antiviral drug, was developed. Now he work in  Hebei QbD Medical Technology Co., Ltd is responsible for CMC R&D, consistency evaluation, CMO and international registration of chemical drugs based on "QbD" and "drug quality management system that meets the requirements of FDA, EMA and NMPA".

Presentation Summary

The Most Common Observations of the Aseptic Manufacturing of Sterile Drug Products

1.Some considerations during the development of Sterile Drug Products.

2.The selection of Aseptic processing.

3.Why parenteral products are in the top lists of the FDA shortage drugs？

4.What is a FDA warning letter?

5.The case analysis and summary of the most common observations of Aseptic processing.