Rebirth of the God-level Xueba

Chapter 1141: I want to fix the rules

   After lunch, I took another two hours of rest. It was getting late, and Hua Rui organized everyone to visit other parts of the pharmaceutical factory.

   is the visiting passage as usual, just walk the other half way, from the second workshop to the first workshop.

   Most people just treat it as a cutscene, and they have not watched it carefully. Dr. Wang also followed lazily, like a crooked Teddy, always wanting to pounce on something and shake his body twice.

   In fact, there is no need for everyone to watch carefully. The standards of Huarui Pharmaceutical Factory are far beyond the pharmaceutical factory that most people know. The British pharmaceutical factory, which Dr. Wang admired so much, cannot keep up with the scale of Huarui pharmaceutical factory. With the rapid development of the pharmaceutical industry in the 1980s, the factory was newly built for two years and has not even been put into production. The machines purchased in advance will fall behind. Under this circumstance, whoever builds is really a better pharmaceutical factory.

   Of course, it is under gmp compliance standards.

   Achieving gmp compliance is not an easy task in itself.

   "Ahem, everyone, please be quiet, let's ask Director Yang to introduce us something, okay?" Wang Junhui, who was the commentator, also saw that everyone was tired, and according to the established policy, Yang Rui was sacrificed.

   What Wang Junhui did not expect was that when Yang Rui uttered the words, a group of people actually became energetic.

   Wang Junhui was a little stunned, even a little uncomfortable. There were obviously beauties standing in front of you, all of them seemed to be falling asleep. As a result, Yang Rui came out, so you were sober?

   She didn't understand that at least half of the people present today were because of Yang Rui.

The value of pcr has increased over time. By the 21st century, the knowledge of pcr is already as clear as a god-in 1986, Yang Ruiming had only been using pcr for more than two years, and Yang Rui's own status had already reached the third level. Skipped.

   Around the world, scholars basically agree that Yang Rui is a second-order scholar, especially in biology.

  The first level is either a Nobel Prize winner or a well-known scholar with a high reputation. The second level is a Nobel Prize achievement, waiting for scholars to receive the Nobel Prize.

  The main reason for most second-tier scholars not to win the Nobel Prize is that they are too old and do not live long enough to wait for the Nobel Prize.

Of course, the number of Nobel Prizes is limited, and new results emerge every year. It is becoming more and more difficult to wait for the Nobel Prize, but for someone as young as Yang Rui, he can wait at least forty or fifty years. Live a little bit. When he is eighty years old, he won't be given the Nobel Prize.

   Within the scope of Greater China, Yang Rui's appeal in biology is unparalleled.

   Many people didn't care much about what they said to the guide, but Yang Rui spoke, and he was completely different.

   Dr. Wang also pricked his ears immediately.

  How many times can you listen to a Nobel Prize scholar's speech in a lifetime?

Yang Rui did not use the microphone like Wang Junhui, but used loud Chinese and said loudly: "What everyone sees now is also the third-level sanitary area. It is the area that has been personally checked by me. I specifically ask me to speak. It is because I hope that when the gmp specification is revised in the future, corresponding revisions can be made."

   Yang Rui asked to fix the gmp specification, but none of the scholars and doctors present felt that there was anything wrong.

   The gmp standard is indeed a standard for the medical and health industries made in the United States. It is indeed a standard in Europe and the United States. It is indeed a standard that has been inspected by many administrators, scholars and legal professionals.

   But so what?

   A second-tier scholar in the world opens up to fix your norms. You can only listen carefully.

   Not to mention, Yang Rui also has an example of the law of independence that proved correct.

  On this matter, Yang Rui can eat for a lifetime. FDA or any country's gmp management agency must pay attention to what he says.

   Of course, it is not that Yang Rui said that the gmp specification will be revised, but for this reason, it is included in the meeting for discussion and a set of documents is given to determine whether to revise or not. That is also reasonable.

   In fact, the gmp specification was originally developed by 6 American professors in the 1960s.

   It was popular in the late 1970s when Americans established it in the form of law and forced major pharmaceutical companies to adopt it before it became popular all over the world. Academically speaking, Yang Rui is too qualified to question it.

   Furthermore, the gmp specification is not static, it has two changes.

   One kind is complicated and difficult, that is, to issue or revise and update laws.

   The other is relatively simple, and commonly used by fda, ​​is to issue guidance documents.

It is relatively rare to change laws and regulations. It is only produced once in a few years or even more than ten years. The guiding document is simple. Of course, the latter is not as effective as the former and is easily overturned by the court. However, given that the fda is in the medical industry, It is a powerful government agency similar to China. Pharmaceutical companies have little chance of direct rebellion. They have to do tricks, usually before the document is issued.

   A group of people erected their ears and listened to Yang Rui.

  Especially the accompanying reporters invited by Huarui, Greenstone Point and Zelecom, they even raised their cameras and tape recorders with a serious look.

Yang Rui looked around, and pointed to the workshop on the other side of the glass very generously, and said: "Our current gmp specifications have made a variety of aseptic requirements for the workshop, but the aseptic level during filling still cannot meet the actual requirements. Demand. Indeed, the bacterial index of one part per million is indeed low enough, but for patients, a single bacteria may be fatal, because our infusion products are ultimately applied to weak patients. ."

   "I'll give an example here, Tyler capsules."

"Just because of an unintentionally opened seal, the capsule was contaminated, which resulted in the death of 7 people in the Taylor capsule incident. It should be avoided by adopting the correct production method. FDA's regulations on anti-interference packaging are very good, but at the same time , We should also see with foresight that the risk of infusion products is higher than that of ordinary tablet products."

Looking at everyone, Yang Rui said the answer directly, saying: "The closed laminar flow device must be fully used in gmp-level pharmaceutical factories to ensure that the chemical liquid is always under the protection of nitrogen. It is necessary to avoid oxidative contact and avoid The disinfection in the workshop is not strict. Similarly, the medicine bottles should also be evacuated and filled with nitrogen to ensure that the oxygen content is reduced to less than one ten thousandth, and they should be directly packaged..."

What Yang Rui said was actually the gmp specification of the first edition of the 1990s, and this specification was naturally extracted from dead people-just like the aviation industry, every complicated specification in the medical industry is for more Of people survived.

   In terms of the production level in the 1980s, nitrogen protection in the sanitary three-level workshop will not increase much cost.

   The effect is extremely prominent.

   Reporters and some scholars have quickly set up records.

   This is not only to raise the problem, but also to give a solution. As long as the news spreads, no drug regulatory agency in any country can afford to take it lightly.

   includes Chinese.

   some of the drug factories

Those who know something about the production of the factory nodded more and even more fascinated.

   Such an appropriate entry point is precisely the correct step of high-level scholars to influence the world.

   Scholars are not like politicians or businessmen. They have always influenced the world imperceptibly, relying on at least the correct ideas at the time to serve as the fulcrum. It is very difficult for Yang Rui to influence the Americans in the form of orders or spread money.

   However, if he puts forward a valuable argument based on correct ideas, it would be difficult for the FDA in the United States not to be affected. For a scholar first, this is also the meaning of exerting influence and value.

  Furthermore, if the fda in the United States is affected, how should the drug regulatory agency in China respond?

  Those who think of this point, especially the Chinese who think of this point~lightnovelpub.net~ can't help but look at Yang Rui.

   I thought it was just a simple, food and drink medical bribery meeting, but it turned out to be a seminar and put forward such a big proposition.

   Most of the reporters didn't know enough about the affairs of academia, or didn't care enough, but at this time, when they contacted the fda, ​​and even more countries' drug regulatory agencies, they were all excited.

   Someone watched Yang Rui finished speaking and raised his hand: "Mr. Yang Rui, do you mean that FDA and other drug regulatory agencies should build pharmaceutical factories based on Huarui's pharmaceutical factory?"

Yang Rui glanced at him. Now he is a British journalist who comes with Zelecan. He doesn't have too much scruples and said: "Hua Rui Pharmaceuticals is higher than the gmp standard, but when countries formulate gmp standards, they should follow high standards. Come and see."

   "Do you mean that the pharmaceutical factories in the United States and the United Kingdom should be in line with the Huarui pharmaceutical factories built in China?" The reporter clearly entered the challenge mode.

Yang Rui didn’t care if he picked things up, and he didn’t hesitate to say in English: “The regulations implemented by China Huarui Pharmaceutical Factory are stricter and more effective. If pharmaceutical factories in the United States and Britain can do this, I think it can save more lives of."

   The proposition of saving lives came out, and it was really difficult for British journalists to answer it.

   The Chinese journalists are struggling to write.

  ……

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