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

The 2025 Edition of Chinese Pharmacopoeia Introduces ICH Concept-Formulating Appropriate Microbiological Standards

The publicity draft issued again by the National Pharmacopoeia Committee introduces ICH risk management concept. The "Publicity Draft of Guidelines for Microbial Limit Examination of Non-sterile Products in Annex 9202" provides practical reference value for enterprises to formulate appropriate microbial limit examination standards for non-sterile products. Dust Amy shares specific contents with you.

2024-07-05

"Technical Guidelines for Pharmaceutical Change Research of Listed Chemical Drugs (Trial)" Questions and Answers on Changes of API"

In order to standardize and guide the research work that relevant preparation holders should carry out when the production process, production site, production batch, quality standards, etc. of chemical raw materials are changed, and to further clarify the technical requirements of relevant preparations when the suppliers of raw materials used in preparations are changed, under the deployment of the State Drug Administration, the Drug Review Center has organized and formulated the "Technical Guidelines for Pharmaceutical Change Research of Listed Chemical Drugs (Trial)" Questions and Answers on Changes of Raw Materials (see Annex). In accordance with the requirements of the Notice of the General Department of the State Food and Drug Administration on the Issuance of the Procedures for the Issuance of the Technical Guidelines for Drugs (No. 9 [2020] of the State Food and Drug Administration), and upon examination and approval by the State Food and Drug Administration, it is hereby promulgated and shall come into force on the date of promulgation.

2024-07-05