How to report production if the process and the actual operation process in the clinical approval do

This can be on the **.

Innovative drugs can be changed after sufficient pharmaceutical research and consideration, of course, there must be a basis to show that the more and more it gets better, such as your lyophilized preparation, for example, the added excipients do not affect the safety of the preparation, increase the stability or reduce the visible foreign body, insoluble particles, etc. Non-innovative drugs have certain dangers and are clicked, but if you do it with the research attitude of the previous example of innovative drugs, there should be no problem.

It is risky to change the prescription process after the clinical approval is issued, the approval document issued to you is for the original process, and the modified process is not recognized, if the product produced by the new process is clinical, the drug produced according to the original process is a phase I clinical trial, and then the sample produced by the new process is used to do the clinical trial later, it is estimated that it is not reasonable, in this case, it is best to consult the experts of the approval center, and it is estimated that it is difficult to modify the process through the approval.

Agree with the point from upstairs. That's true. The clinical approval is down, and it is approved according to your original process. The principle is to do clinical according to the original process, and if you use the new process now, it is a powder injection, and you should do it again.

The clinical samples should be after the prescription is changed, and I don't know if the first phase of clinical use needs to be redone. However, there are risks associated with changing prescriptions, and the CDE does not encourage them.

Learned, very useful. At least it gave me an idea of how to deal with such a problem.

According to the requirements of the quality system process, the relevant personnel should be organized to review, form meeting minutes, and the review will decide whether to operate according to the process regulations or according to the actual operation, and modify the process regulations. Implemented according to the review resolution. The process regulations that need to be modified are also issued and implemented after approval by the authorized leaders in accordance with the requirements of the relevant system documents.

The formulation of the problem is not very clear. First of all, when this discrepancy occurs, it depends on how your system documents are stipulated. Under normal circumstances, the actual process parameters should be adjusted according to the "Process Technical Regulations".

If it turns out that the "Process Technical Regulations" cannot meet the needs (or do not meet the actual situation), the technical regulations should be revised according to the requirements of the system documents, and then implemented according to the revised technical regulations.

Deviation surveys should be conducted, and if process modifications do need to be made, change management should be conducted.

Submit an application to the process technology department to update the process technology regulations.

Be sure to refer to the process of the EIA report! The feasibility study report is too rough and cannot be very accurate, the EIA report is prepared by the EIA unit, which is very professional, and the EIA expert review is subject to the EIA report, and the feasibility study is basically not read. This is very important.

Over time, the technologist can improve it, as long as the emission standards are not lowered should not be a problem.

According to the treatment process in the EIA, because the project acceptance is carried out according to the EIA approval.

It seems that this is very common. If you don't do an EIA, it's not very clear. It shouldn't be a big deal. As long as the effluent standard is not lowered, it will be done.

It depends on what medicine you apply for.

If it is a Class 6 imitation, it is directly a production approval. Because clinical trials have already been done by others.

The approval of a new drug must first be submitted to the clinic, and the clinical trial can be completed before it can be batched.

Of course, it is a clinical approval, and the order of new drug application is: pharmaceutical research and development --- reported to clinical --- clinical trial--- reported to production--- issuance number and certificate.

Production process regulations: it emphasizes: product name, dosage form, prescription, operation requirements of production process, quality standards and technical parameters of materials, intermediate products, finished products and storage precautions, calculation methods of material balance, requirements for finished containers and packaging materials, etc.

Post operation method: it emphasizes: production operation methods and requirements, review and review of key operations, intermediate product quality standards and control, safety and labor protection, equipment maintenance, cleaning, abnormal situation handling and reporting, process hygiene and environmental hygiene.

Standard Operating Procedures: It emphasizes: title, number, maker and date, reviewer and review date, approver and approval date, issuing department, production date, distribution department, title and text.

When the workshop wants to produce new parts, it is necessary to first formulate the machining process specification of the part, and then prepare for production according to the process specification. For example, the analysis and study of key processes in the processing technology of new parts; Prepare the required knives, clamps, measuring tools (purchased or manufactured); procurement or manufacture of raw materials and blanks; The purchase of new equipment or the modification of old equipment must be carried out according to the process.

1 Product features, quality standards.

2. Characteristics of raw materials and auxiliary raw materials and quality standards that should be met for production.

3. Production process.

4. Main process technical conditions and quality standards of semi-finished products.

5. The main points of the production process.

6. The inspection items and times of the main technical and economic indicators and finished product quality indicators.

7. Inspection items and times of process technical indicators.

8. Characteristics and quality standards of special equipment.

Due to the imperfection of production organization and process equipment management, production process accidents lead to process and equipment system failures, hidden dangers and accidents, which lead to steelmaking safety accidents!