DST Durst team went to a pharmaceutical company in Sichuan to coach FDA on-site inspection!
Release time:
2024-10-25
Recently, DST DST experts went to a pharmaceutical company in eastern Sichuan to give all-round guidance to the company's 7-day FDA on-site inspection. They provided corresponding FDA-related consulting services to the pharmaceutical company many times in the early stage. The modules such as quality system, facilities and equipment system, material system, production system, packaging and labeling system, and laboratory control system have been improved and perfected as a whole, prepared for on-site FDA inspection. The FDA inspector conducted a 7-day in-depth inspection, accompanied by DST experts throughout the inspection process, and was approved by the inspector.
Recently, DST DST experts went to a pharmaceutical company in eastern Sichuan to give all-round guidance to the company's 7-day FDA on-site inspection. They provided corresponding FDA-related consulting services to the pharmaceutical company many times in the early stage. The modules such as quality system, facilities and equipment system, material system, production system, packaging and labeling system, and laboratory control system have been improved and perfected as a whole, prepared for on-site FDA inspection. The FDA inspector conducted a 7-day in-depth inspection, accompanied by DST experts throughout the inspection process, and was approved by the inspector.
This FDA site inspection guide Durst DST arranged for senior, experienced teachers to the site support. Directs site arrangements prior to inspection, including assisting in handling and answering questions from the prosecutor. Prior to this, Durst DST had cooperated with the company for two years. In the early stage, it has helped the company successfully obtain FDA certification for the isolator non-final sterilization production line, which is PAI inspection. This time involves PAI inspection of sterile preparations (not terminal sterilization) from sterile materials. In the early stage, DST again arranged the team to the site for guidance.
Real knowledge comes from practice. DST Durst's expert team has experienced many international GMP certification inspections and has rich experience in dealing with GMP certification inspections. It can help pharmaceutical companies to make overall improvement from all aspects when they should be GMP certification inspections, so as to ensure the smooth development and passing of GMP certification inspections. At the same time, DST Durst also has rich experience and many successful cases in the construction of quality system, simulation audit, GMP certification, etc. It has helped many pharmaceutical companies pass GMP certification. Recently, it has coached Sichuan Huiyu Pharmaceutical and Chengdu Shengnuo Biology to pass FDA certification in the United States. Most of DST Durst's expert teams have worked in well-known foreign companies in the industry or worked and studied in foreign pharmaceutical companies. They have rich experience, novel ideas and concepts and solid professional skills, can bring better customer experience and results for customers.
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. It has repeatedly used simulation inspection and certification on-site counseling to help pharmaceutical companies pass international certification audit and inspection, and has successively helped Huiyu Pharmaceutical, CR Sanjiu, Sinopharm Zhongsheng, Hanteng Bio, Raffles Pharmaceutical and other pharmaceutical companies pass international certification audit and inspection.
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