All times mentioned are CEST.
Sprecher
Francois Vandeweyer, Freelance Consultant, formerly Janssen Pharmaceuticals
Zielsetzung
In a relatively short period of time, China has become the leading global supplier of APIs in terms of volume. China is the world’s leading producer and exporter of active pharmaceutical ingredients (APIs) by volume, accounting for 20% of total global API output. According to WHO China produces over 2000 APIs, with annual production capacity exceeding 2 million tons.1
China first introduced GMP in 1988, and the latest GMP regulations are the 2010 revised edition of Good Manufacturing Practice for Pharmaceutical Products (with effect from 1 March 2011). While CFDA is responsible for developing regulations and standards for GMP, it is mainly provincial and local authorities that are responsible for inspection and certification.1
The understanding of GMP and Registration Procedures for APIs are thus important to know and understand.
This online training course provides an overview of the legal requirements regarding APIs in China.
1Source: WHO Report https://www.who.int/phi/publications/ 2081China020517.pdf?ua=1
Zielgruppe
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Marieke van Dalen
- Health authorities in China
- The Chinese Drug Master File system
- Bundled review
- Specifics for the Chinese API Drug Master File
- Common deficiencies
Francois Vandeweyer
- Chinese GMP main topics
- Chinese Drug GMP on site inspection focus points
- Chinese GMP annexes with focus on Biologicals
- Chinese quality management and equipment strategy to compete with the West
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