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On the evening of November 12, the Food and Drug Inspection Center of the State Drug Administration and the National Vaccine Inspection Center issued a notice to publicly solicit opinions on the "Guidelines for Quality Management of Drug Co-production (Draft for Solicitation of Comments)"
.
For the author, it is difficult and incapable to interpret the full text.
I would like to have a brief chat with you.
If there is any mistake, please leave a message and prove it
.
Where are the risks of co-production?
1.
Quantity of residue
Quantity of residue
After the production process is over, we will have a cleaning process, and some of the relatively new equipment even has an online cleaning function
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Whether online cleaning is necessary depends on the difficulty of manual cleaning of the equipment itself
The blade of the soybean milk machine is a part of the risk of cleaning.
It may cut your hands and is difficult to clean.
It is easy to form a sanitary corner
.
The rice cooker has no similar structure and is easy to clean
In addition, in order to ensure the sanitation of clean dead corners, cleaning agents may be added
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The application of detergent is actually more embarrassing.
2.
Residue activity or toxicity
Residue activity or toxicity
Different reagents have different activities or toxicity.
For example, the lethal dose of potassium cyanide is between 50-250 mg, which is similar to the lethal dose of arsenic (As2O3)
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Therefore, there are similar plots in many spy films.
But we also know that the quality inspection of drugs is often based on the Pharmacopoeia
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Pharmacopoeia is based on impurities such as isomers generated in the process, or specific components contained in the raw materials for testing
The Japanese nuclear leak, we had never been seen everywhere also buy salt, after asking price analytically pure sodium chloride, and my leader said, "It is not, or can be purchased as a reagent consumption of salt thing"
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The leader said, "No, analytically pure or chemically pure, mainly depends on the purity of the content, but if they used other toxic components in their aliquots or mixers before? It is risky
In addition, it depends on the purpose of the product
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Taking cold medicine as an example, the duration of eating is generally not long
Highly toxic impurities in short-term medication and low-toxic impurities in long-term use should be paid special attention
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In case there is a shared production facility or environment, the risk must be assessed
As far as the actual situation is concerned, some large companies may start building factories and equipment during the research and development process
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Collinearity is actually a last resort, or considering that the production volume of a single product is not saturated
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But there may be accommodating to a specific product, such as this product should be protected from light and low temperature, then the process parameters of other products should be changed, so that it can be adapted as much as possible
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This is something that the enterprise itself must consider, even if there is no guideline
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