Deviation, want you to "tube"

Recently, I launched an article on writing a deviation survey. I received feedback from some readers and wanted to know something about the definition, management and process of deviation events. So this time, I will talk about deviation management and process first. To manage a survey well, in addition to a good management process, you also need to learn how to manage it effectively. Here are some insights from the DST team.

2024-10-25

Material acceptance, piece by piece identification how to manage

DST: For EU GMP sampling, item-by-item sampling identification is expensive for enterprises and is not easy to control, so how to control in the actual implementation process to meet the sampling requirements for materials:

2024-10-25

Good news! Durst customer Sichuan Huiyu injection products successfully went to sea in the United States!

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.

2024-10-25

Warmly congratulate DST Durst on reaching FDA cGMP project cooperation with well-known radiopharmaceutical pharmaceutical companies in Sichuan!

DST Durst recently signed an FDA cGMP project cooperation agreement with a well-known and established radiopharmaceutical company in Sichuan. DST Durst will intervene in the design stage to ensure the GMP compliance of enterprises from the design stage. Durst DST will be involved throughout the FDA's cGMP program to help companies successfully pass inspections.

2024-10-25

Congratulations on passing! Durst Helps Jiangsu Spectrum New Biology Obtain EU GMP QP Conformance Declaration!

At the beginning of may 2024, DST (DST) customer Jiangsu pu Xin biopharmaceutical co., ltd (hereinafter referred to as "pu Xin bio") obtained the EU GMP conformity declaration issued by the EU quality authorized person (Qualified Person, QP), marking the successful completion of EU QP project cooperation between pu Xin bio and DST!

2024-10-25

Milestone events! DST DST successfully obtained FDA cGMP plant design project of a biochemical products co., ltd. in Guangzhou

Recently, DST and Guangzhou biochemical products Co., Ltd. signed a FDA cGMP plant design project cooperation agreement. This time, OTC products involving the enterprise need to be exported to the U.S. market. DST DST has helped a number of enterprises to complete the consulting and plant design services in the U.S. market.

2024-10-25

DST experts to Shenzhen well-known pharmaceutical companies to carry out EU and PIC/S projects

Recently, a team of experts from Durst went to a well-known pharmaceutical company in Shenzhen to analyze the gap between the EU and PIC/S projects. The company mainly produces inhaled preparations and is one of the largest producers of BFS products in the country. The goal is to help the company conduct overseas audits. The company's products from multiple production lines are planned to be exported to Southeast Asia and the EU market. Durst arranged four senior experts, including experts from various sectors such as QA, production, QC and computerized system verification, to the site for system inspection to help enterprises comprehensively assess the current risks.

2024-10-25

Warmly congratulate DST Durst and Shanghai well-known radiopharmaceutical companies to reach a plant design project cooperation!

Durst DST has recently launched a cooperation project with a well-known radiopharmaceutical enterprise in Shanghai. The purpose of this project is to help the enterprise to review the QC laboratory (radioactive laboratory and non-radioactive laboratory), production workshop (including synthesis accelerator), hot room for synthesis and preparation, preparation room and other process sections of the whole factory in the design stage of the enterprise. At the same time, it also involves the warehouse management, public system design and management.

2024-10-25

DST experts go to famous pharmaceutical enterprises in Sichuan to carry out GMP audit project!

At the end of December, Dust DST arranged FDA GMP experts to conduct FDA cGMP on-site audits of well-known pharmaceutical companies in Sichuan. This audit is a GMP audit of the company's API project. This audit is Dust DST's European and American GMP requirement audit for the new production line just after the enterprise passed the FDA inspection of sterile bulk drugs and sterile preparations in December. This audit involves the comprehensive inspection of three bulk drug production lines and QC and public systems. This is another collaboration between Durst DST and the company after several project collaborations.

2024-10-25

DST Durst team to Suzhou well-known biopharmaceutical enterprises to carry out QP audit project!

2024-10-25