Blog

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


Release time:

2024-10-25

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.

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.

 

Under the collection, the competition of pharmaceutical enterprises is becoming more and more fierce, the price and product "double internal volume" superimposed on the specific economic cycle, relying on a single variety of a single region to achieve scale profit logic gradually dissipated, in order to seek more profits and more markets, "going out" has become the common development strategy of domestic pharmaceutical enterprises. European and American certification and PIC/S certification may become the next opportunity "outlet". According to the rich experience of European and American GMP certification and PIC/S certification, the team of experts in Dust has coached a number of pharmaceutical companies to go to sea through European and American GMP certification and PIC/S certification.

 

Since the establishment of DST Durst, DST Durst has taken the mission of enabling more pharmaceutical enterprises to reach the international top quality management level, the concept of customer first, and its own specialty as its hard strength, focusing on serving international GMP consulting work, including FDA, EU-GMP, FDA, PIC/S, QP and other certification, auditing and verification work. It has successively provided international GMP services for Lizhu Pharmaceutical, Baiyunshan Pharmaceutical, China Resources Sanjiu, North China Pharmaceutical, Kangtai Biology, Baiji Biology, Longsha Biology, Sinopharm Zhongsheng and other enterprises, and has been recognized by customers. Has repeatedly used gap analysis, certification on-site counseling, simulation audit and other ways to help pharmaceutical companies through international certification audit and inspection, has helped Huiyu Pharmaceutical, China Resources Sanjiu, Sinopharm, Hanteng Bio, Raffles Pharmaceutical and other pharmaceutical companies through international certification audit and inspection.

Key words:


Related Blog


CDE: Notice on Trial Submission of Electronic Application Data for Drug Registration by Network Transmission

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

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.

2024-07-05

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.

2024-07-05

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

Please collect the sea enterprises! Names and Websites of National and Regional Food and Drug Administration in Southeast Asia (Encyclopedia)

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