Congratulations! Durst and Chongqing Zhixiang Jintai Biology Successfully Held EU GMP QP Project Launch Meeting
Release time:
2024-10-25
Recently, the team of experts from Dust went to Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. and successfully launched the "Chongqing Zhixiang Jintai Bio-EU GMP QP Project" kick-off meeting.
Recently, the team of experts from Dust went to Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. and successfully launched the "Chongqing Zhixiang Jintai Bio-EU GMP QP Project" kick-off meeting.
Zhixiang Jintai biological leadership, department heads and key personnel involved in QP project work and Durst expert team attended the conference.
After the start-up meeting, DST also reviewed the design of the new plant to ensure that the design of the plant meets the requirements of GMP standards in Europe and the United States. DST was approved by the Zhixiang Jintai team this time.
Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. was established in 2015 and is located in Chongqing International Biological City. It is an innovative biopharmaceutical company driven by antibody drug discovery technology, focusing on the treatment of autoimmune diseases, infectious diseases and tumors. Engaged in the research and development, production and commercialization of antibody drugs. Zhixiang Jintai always pays attention to the unmet clinical needs, adhering to the tenet of "making good medicine for patients", and continues to provide patients with reliable and affordable innovative biological drugs.
This Zhixiang Jintai Biological EU QP project is mainly aimed at communicating with the quality system, new workshop projects and key equipment and carrying out specific communication on the follow-up work. The purpose is to make systematic analysis to further improve the whole quality system to fully meet the EU cGMP standards and to prepare for the subsequent acquisition of QP conformity statement.
EU GMP first introduced QP system in 1975. The successful experience of nearly 50 years shows that this system is an advanced quality management mode, which can effectively guarantee the quality of drugs and become one of the core of EU GMP system.
The EU has very strict requirements for QP qualification. The European Commission Directive DIRECTIVE 2001/83/EC and the EU GMP Annex 16 "Certification and Batch Release of Quality Authorized Person" define QP's legal status, qualification and responsibility in detail. Its professional level requirements make QP become the expert and authority in the pharmaceutical industry.
Therefore, in recent years, more and more pharmaceutical companies are committed to verifying that their industrial bases and their quality management systems are in line with EU GMP standards through QP compliance checks, as another milestone in the company's global layout and laying the foundation for the global layout of pharmaceutical production and commercialization.
DST Durst has a lot of case experience in coaching pharmaceutical companies to pass QP audit. He has successively provided QP audit consulting services for Kangtai Biology, Guangdong Raffles, Suzhou Yasheng Pharmaceutical, Beijing Kangle Guardian, Borice Biology, Pruxin Biology, Liangchen Biology, Anji Biology, Hengyu Biology, etc., and coached them to pass QP audit. In the implementation of QP audit consultation, DST DST EU standard requires experts with EU QP qualification and relevant technical experts to first analyze the gap between system documents and on-site for cooperative pharmaceutical enterprises, and at the same time, conduct pre-audit training for relevant department personnel of pharmaceutical enterprises, arrange QP simulation audit, and guide pharmaceutical enterprises to carry out rectification and optimization according to the QP audit report issued, so as to successfully pass QP audit. In this mode, many times to help pharmaceutical companies successfully pass the QP audit, I believe that the Zhixiang Jintai biological QP audit project will also be successfully completed.
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