Shanghai Jinma on the daily management of imported standard products - Database & Sql Blog Articles

With the development of the standard products, some problems have also been encountered in the process of use. If the management is poor or exceeds the service life, the concentration is lowered. This makes it possible to pass a drug with a low content to a qualified drug, and it also affects the quality control of the drug substance and the intermediate. Our company upgrades the problem of product use management. Let's take a look at the daily management of Shanghai Jinma on imported standard products:
First, management requirements:
1. To grasp the source of the standard product, use the nationally recognized standard product and verify it as required;
2. Account management and registration of standard products should be done as required, and stored under specified conditions;
3. It is necessary to verify the storage conditions and service life of the standard products, the opened standard products and the standard stock liquids at work, and make clear regulations and make various records;
4. It is recommended that the supplier of the standard product also provide the standard product instruction manual, and specify the use period and storage conditions.
Second, in the management method of standard products, there are still problems at present. First, the source of standard products is not standardized. On-site inspection found that some companies used standard products that were refined APIs or “work standards”. Although they were approved by the relevant departments, most of the enterprises did not specify their re-registration period and storage conditions, and their use period was not verified. And the record is incomplete, it is difficult to trace the source.
Secondly, standard product management is not in place. At present, most enterprises do not verify the standard products before they are used. Some enterprises make the standard products into higher concentration stocks for convenience, but fail to check their stability and storage period; some enterprises After the opening of the standard product management is not in place, still with the unopened standard products continue to use, no mark on the packaging, and so on.
Third, note:
When the standard or standard product is used for inspection, the quality management department manager will review it and report it to the deputy general manager for approval. The material department will directly purchase it from the provincial drug inspection office or Shanghai Huding Biotechnology Co., Ltd. Or a verification report of the standard.
The standard products prepared by the company are submitted by the QC inspectors of the quality control department, and the production department issues the production instructions. The quality control department carries out inspection according to the standards of the standard products. After the inspection is passed, the quality management department manager will review it and the deputy general manager will approve it.
Fourth, the content determination:
Since the reference substance of traditional Chinese medicine is extracted or refined from organic solvent, the water content is generally low. Therefore, in the case where there is no prescribed moisture content at present, it is only required to place the chemical reference substance with higher melting point at 105 °C. dry. At the same time, for unstable reference materials, it can be applied after drying in a silica gel or phosphorus pentoxide vacuum dryer. Strictly speaking, the reference material should specify the limit of drying weight loss, and the residual organic solvent should also be specified.
According to the standard experts of Jinma, the methods for determining the content and impurity content of chemical reference materials in the past generally include: volumetric method, gravimetric method, etc., and also determined by ultraviolet E value. However, due to the development of modern science, especially the extensive application of spectral chromatography technology, the above-mentioned capacity and weight method can only obtain the total content of total components such as total alkaloids and total flavonoids, and the high-performance liquid phase method and thin layer are now available. Scanning method, etc. not only simple operation method, but also relatively accurate results