DST Dust went to Hefei, Anhui Province, well-known biological vaccine enterprises to audit vaccine products!

Recently, DST Durst experts went to a well-known biological vaccine enterprise in Hefei, Anhui Province to conduct a 4-day on-site inspection and audit of vaccine products. Prior to this, DST Durst had provided many GMP-related consulting services to the pharmaceutical enterprise. The audit of vaccine products mainly focused on the overall improvement and perfection of quality system, facilities and equipment system, material system, production system, packaging and labeling system, laboratory control system and other modules, help the enterprise to find the quality system and production system problems and deficiencies, improve the overall level of GMP.

2024-10-25

DST Durst team went to a pharmaceutical company in Sichuan to coach FDA on-site inspection!

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.

2024-10-25

Have you written the quality manual of pharmaceutical enterprises?

In an audit of the quality management system documents of pharmaceutical companies, the consultant DST found that there were some problems in the development of quality manuals for pharmaceutical companies:

2024-07-05

Supplier audit, colleagues need not worry, have reference

Supplier Management As part of the daily work of QA, materials are subject to strict qualification and on-site review before they are identified as qualified suppliers. As required by China GMP(2010 Edition), Chapter 10 (Quality Control and Quality Assurance), Section 7 (Evaluation and Approval of Suppliers) and Appendix (Computerized Systems):

2024-07-05

Congratulations! Durst and Chongqing Zhixiang Jintai Biology Successfully Held EU GMP QP Project Launch Meeting

Recently, the team of experts from Dust went to Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. and successfully launched the "Chongqing Zhixiang Jintai Bio-EU GMP QP Project" kick-off meeting.

2024-07-05

State Food and Drug Administration: Blood Products Appendix (No. 70 of 2024)

As one of the key regulatory objects of the national drug administration, blood products, like vaccines, need to implement the batch issuance system of biological products. The "Administrative Measures for the Batch Issuance of Biological Products" (promulgated by the State Administration of Market Supervision and Administration No. 33 in 2020) implemented on March 1, 2021 clearly states that the batch issuance of biological products refers to the approval of the State Drug Administration for marketing. For vaccine products, blood products, in vitro diagnostic reagents for blood source screening, and other biological products specified by the State Drug Administration, before each batch of products is sold or imported, the activities of issuing certificates for batches that meet the requirements are reviewed and inspected by the designated batch issuing agency. Products that have not been issued in batches may not be marketed or imported.

2024-07-05

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