DST Durst team to Suzhou well-known biopharmaceutical enterprises to carry out QP audit project!
Release time:
2024-10-25
In the first week of December, DST Durst arranged three senior consultants to conduct EU QP simulation inspection at a well-known biopharmaceutical company in Suzhou. The inspection lasted for 4 days. In this QP audit project, Dexter arranged experts with EU QP qualification and relevant technical experts according to EU standards, conducted pre-audit training for relevant department personnel of the company, arranged QP simulation audit, guided the stock solution and preparation workshop of the company's GMP production line according to the QP audit report issued, and provided rectification and optimization suggestions so as to successfully pass the QP audit.
The biopharmaceutical enterprise is an enterprise dedicated to the field of cell therapy. It has Suzhou headquarters (10000 ㎡ GMP factory and R & D center), Shenzhen and Shanghai bases, and has initially formed a national layout of production base network. The North Carolina base in the United States is also under construction, with a simultaneous global layout. A dedicated nucleic acid platform for cell drugs, a suspension serum-free virus production platform, a fully enclosed cell process development platform and a quality control testing technology platform have been built, creating a highway from discovery to product delivery of cell drugs. The platform has supported a number of partners to successfully hatch a variety of CAR-T, TCR-T, stem cells and other drugs......
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 Appendix 16 "Certification and Batch Release of Quality Authorized Person" define the legal status, qualification and responsibility of QP in detail. Its professional standard requirements make QP become an expert and authority in the pharmaceutical industry.
Therefore, in recent years, more and more pharmaceutical companies are committed to passing QP inspections to verify that their industrial bases and their quality management systems have complied with EU GMP standards, 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 extensive case experience in coaching pharmaceutical companies to pass QP audits, providing QP audit consulting services for Kangtai Bio, Guangdong Raffles, Suzhou Yasheng Pharmaceutical, and Beijing Kangle Guardian, and coaching through QP audits. 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, we have helped pharmaceutical companies successfully pass the QP audit many times. We believe that the QP audit project with this biopharmaceuticals company will also be carried out smoothly.
Key words:
Related Blog
Durst DST Regulation Group, noting that on July 1, 2024, the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as CDE) issued a trial notice on the submission of electronic application materials for drug registration by network transmission. Starting from July 1, 2024, the trial work on the network transmission of electronic application materials for drug registration will be started, and applicants can submit electronic application materials for drug registration through network transmission. There is also an attachment: the reservation for network transmission of electronic declaration materials and the description of operation steps, which is convenient to guide everyone to submit electronic declaration materials.
2024-07-05
Recently, after the products of DST DST customers Sichuan well-known pharmaceutical companies passed PAI inspection in November 2023, they were officially approved in December. In June 2024, they officially sent several batches of products to enter the US market. This exciting news came at the time of the third FDA project audit of the client again. The customer is located in Neijiang City, Sichuan Province, an ancient city between Chengdu and Chongqing. The success of Huiyu Pharmaceutical has made this city more attractive to pharmaceutical people! Once again, congratulations to the customer products officially go to sea! The entry of products into the US market shows that DST customers have been strictly implementing quality management according to high standards, continuously optimizing production processes, and producing more high-quality products higher than national standards.
2024-07-05
Recently, after the products of DST DST customers Sichuan well-known pharmaceutical companies passed PAI inspection in November 2023, they were officially approved in December. In June 2024, they officially sent several batches of products to enter the US market. This exciting news came at the time of the third FDA project audit of the client again. The customer is located in Neijiang City, Sichuan Province, an ancient city between Chengdu and Chongqing. The success of Huiyu Pharmaceutical has made this city more attractive to pharmaceutical people! Once again, congratulations to the customer products officially go to sea! The entry of products into the US market shows that DST customers have been strictly implementing quality management according to high standards, continuously optimizing production processes, and producing more high-quality products higher than national standards.
2024-07-05
Argument! Hengrui Warning Letter, Is It FDA's Political Sanction?
Tieguai Liu saw many posts about whether there were political factors in Hengrui's warning letter. Today, Tieguai Liu will discuss this matter with everyone's concerns. First of all, we are very sensitive to see that the "first brother" of China's pharmaceutical industry has received a warning letter from the FDA of the United States. For today's Sino-US environment, we naturally think of the FDA's sanctions against the first brother due to the influence of US politics. It is completely understandable from everyone's interpretation. The following Tieguai Liu will discuss with you from both positive and negative dimensions:
2024-10-25
Durst DST continues to pay attention to the drug regulatory policies of countries around the world to help companies go to sea, and the following is the drug regulatory situation in Southeast Asian countries and regions.
2024-10-25
Contact Information
Durst (Shenzhen) Consulting Service Co., Ltd.
Contact Phone:86-18826007039
E-mail:consulting@delsalt.com
Address: C19, Building 1, Yongheyuan, Zhuangbian Community, xixiang street, Bao 'an District, Shenzhen City, Guangdong Province
Sweep to identify concerns:
Scan attention consultation