Heavy! The General Department of the State Administration publicly solicits the announcement of the "Quality Management Standards for the Production of Pharmaceutical Excipients" and "Quality Management Standards for the Production of Pharmaceutical Package Materials" (draft for comments)

Durst DST Regulation Group noted that on July 18, 2024, the General Department of the State Drug Administration issued two drafts for comments at the same time, which are on the "Quality Management Standard for the Production of Pharmaceutical Excipients" and the "Quality Management Standard for the Production of Pharmaceutical Packaging Materials". This is the relevant production quality management standard issued by NMPA after the related review of pharmaceutical excipients and packaging materials, requiring feedback through electronic E-mail before August 20, 2024.

2024-10-25

The National Drug Review Center issued: Chemical generic injection overfilling research technical guidance notice.

Durst DST Regulation Group noted that on July 05, 2024, the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as CDE), in order to further clarify the technical requirements for overfilling research on chemical generic injections and improve the evaluation standard system for chemical generic injections, according to the work deployment of the State Drug Administration, the Drug Examination Center organized and formulated the "Technical Guidelines for Overfilling Research on Chemical Generic Injections", which will be implemented from July 5, 2024

2024-10-25

Heavy! CFDI Releases Guidelines for On-site Inspection of Cell Therapy Products (Draft for Comments)

Durst DST Regulation Group noted that on July 12, 2024, the Food and Drug Review and Inspection Center of the State Drug Administration (hereinafter referred to as CFDI) issued opinions on soliciting "Guidelines for On-site Inspection of Cell Therapy Products" and feedback through electronic E-mail before July 29, 2024. This is also the second inspection guide on specific drugs issued by CFDI in conjunction with the Special Drug Inspection Center of the State Food and Drug Administration, following the "Guidelines for the Inspection of Radioactive Drug Production" (draft for comments "issued on July 10. The following is the relevant content of the announcement:

2024-10-25

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.

2024-10-25

What happens when the root cause of the deviation is human error?

As technology advances, human error in manufacturing is becoming more apparent every day. In the pharmaceutical industry, more than 80% of deviations are caused by human error, but unlike process or equipment failures, human error is usually not investigated in depth, and despite the underlying cause, companies will eventually only provide retraining for the relevant employees, and this simple method is usually evaluated as "imperfect quality system". To this end, Amy and everyone together to see how to identify the root causes of human error and really reduce human error.

2024-10-25

Hengrui Warning Letter Incident 4-Point Reflection and Warning Letter Reversal?

Not surprisingly, there was still an accident. Hengrui's Warning Letter was still present as promised. This will be a sensation. As for the 483 defects in Hengrui's early stage, in fact, after reading it, the author also made analysis and communication with many big players in the pharmaceutical industry. Warning the arrival of Letter may be a matter of time, there is still a chance to reply after all. As a research and development enterprise, Hengrui is a landmark pharmaceutical enterprise in our country and a leader in our pharmaceutical industry. As an industry practitioner, I feel a little heavy. As one of the consulting companies promoted by going overseas, we have helped many companies complete inspections and successfully go to the U.S. market. We also hope that through our efforts, the level of the pharmaceutical industry will be improved. Further improvement.

2024-10-25

National regulations, pharmaceutical companies who sample compliance?

DST teacher recently in the audit process, found that some customers of the sampling work by the QA to be responsible for, some pharmaceutical companies by the QC sampling, so who is responsible for the sampling, who is responsible for the authorization is appropriate? Today we will come to discuss the issue of sampling, let us start from the regulations, look at the relevant provisions.

2024-10-25

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

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