My name is Chen Xin. Some Puyou who know me know that I was originally in the wind power industry and turned to the pharmaceutical industry by mistake. As the saying goes, the layman looks at the excitement, the insider looks at the doorway, I belong to the layman, and watched the excitement of the year. Indeed, the pharmaceutical industry is a bit lively.
Flight inspection, data verification, data integrity, pharmaceutical informationization, data reliability. . . The speed and frequency of the CFDA policy is faster than the speed of upgrading our company's documents. Indeed, it is not surprising and lively. My business leaders want to spend a lot of money on the so-called "MES" system, the quality manager opens his mouth to shut up the data integrity every day (now called data reliability), shutting up the mouth is the computerized system verification, it seems that the pharmaceutical does not make a reliable data Sexual and computerized system verification is not even tall.
The company that is currently working is the second pharmaceutical company that I am migrating. The benefits are not bad. It also has a certain reputation. Traditional Chinese medicine, chemical medicine, oral and aseptic products are available. The coverage is large and wide. In fact, there are problems at present. As everyone knows, there are still a lot of things that can't see the light. Some I know, there are more, I don't know, I will take a Chinese medicine variety as an example to talk about my practical experience in data reliability. (Note: I don't know how to call data integrity, and I don't understand the guide. I just think that the first premise of integrity, the data is accurate, the accuracy can't be done, and the completeness is not a bit of a tear)
Reliable raw materials
Chinese herbal medicine is the largest raw material used by our company. In the past, we also have our own GAP base. The so-called GAP is actually just hanging a brand in such a small piece. It is true that the medicinal materials are harvested in the season, most of them go to the farmer's house-to-house acquisition, and more Chinese herbal medicines are purchased from Anguo, Zhangzhou and other places, one car and one car, and a batch of materials. We do not know whether the pesticides used in the year, place of production and planting process of these original medicinal materials are consistent. In order to "complete data", we have compiled a lot of records, which are as reliable as possible on the surface.
Reliable extraction
When it comes to extraction, it is a big problem. The first is that the registration process and the actual production process are not in accordance with the pharmacopoeia and the registration process. Some have a high rate of paste collection, some have a low rate of paste, and the process parameters fluctuate greatly. , has been in a state of entanglement, how to remember the actual record? Therefore, it has derived the characteristics of the company itself, called the "GMP" record. I probably count that the main work of the quality department is not in quality assurance, but that most of the time is tossing records and deviations. In order to come out to the GMP auditor, the inspectors seem to have fewer problems, more complete and more reliable.
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