Chapter 1160

At the end of lunch, after another two hours' rest, it was getting late, and huaruicai organized people to visit other parts of the pharmaceutical factory.

It's still a visit corridor, just another half way from the second workshop to the first workshop.

Most people just take it as a show and don't watch it carefully for a long time. Dr. Wang also follows him lazily, like a teddy walking around, always trying to jump on something and stir his body.

In fact, there is no need for people to watch carefully. The standard of Huarui pharmaceutical factory has far exceeded that of most people. For example, the British pharmaceutical factory that Dr. Wang highly praised can not catch up with the scale of Huarui pharmaceutical factory. With the rapid development of the pharmaceutical industry in the 1980s, the new factory has been built for two years, and even has not been put into production, so the machines purchased in advance will lag behind. In this case, whoever builds later is the better pharmaceutical factory.

Of course, it is under the GMP compliance standard.

It is not easy to achieve GMP compliance in itself.

"Cough, please be quiet. Let's ask director Yang to introduce something to us, OK?" Wang Junhui, the commentator, also saw that everyone was tired. According to the established policy, he sacrificed Yang Rui.

What Wang Junhui didn't expect was that a group of people were really in the spirit when Yang Rui's two words came out.

Wang Junhui was a little stunned, even a little resentful. There were beautiful women standing in front of you, and they all seemed to fall asleep. As a result, Yang Rui came out, and you woke up?

But she didn't understand that at least half of the people present today were due to Yang Rui.

PCR The value of PCR increases with time. By the time of the 21st century, the invention of PCR has become a god like invention. In 1986, Yang Rui invented PCR only for more than two years. Yang Rui's position has leapt three times.

In the world, Yang Rui is generally recognized as a second-class scholar, especially in biology.

The first level is either the winner of the Nobel prize or the famous scholar with high reputation. The second level is the scholar who has made the Nobel Prize and is waiting for the Nobel Prize.

The main reason why most second-class scholars can't get the Nobel Prize is that they are too old to live long enough to wait for the Nobel Prize.

Of course, the number of Nobel prizes is limited, and new achievements emerge every year. It's more and more difficult to wait for the Nobel Prize. But Yang Rui, a young man, can at least wait 40 or 50 years. If he can live a little longer, he can't even wait until he is 80 years old.

Within the Greater China region, Yang Rui's internal appeal to biology is unparalleled.

Many people don't care much about what the commentator says, but Yang Rui says that he is quite different.

Dr. Wang also immediately pricked up his ears.

How many times can a Nobel laureate listen to a speech in his life?

Instead of using the microphone as Wang Junhui did, Yang Rui said in loud Chinese: "what you see now is also a health level III area, which has been checked by me personally. I especially ask that I speak it because I hope that when the GMP standard is revised in the future, we can make corresponding amendments."

Yang Rui was about to revise the GMP standard, but none of the scholars and doctors present felt that there was anything wrong.

GMP The norms are indeed the norms of the medical and health industry in the United States, the prevailing norms in Europe and the United States, and the norms that have been inspected by a number of administrative personnel, scholars and legal professionals.

But so what?

As a second-class scholar in the world, if you want to revise your rules, you have to listen.

Not to mention, Yang Rui also has the case that he only resisted LV boding and proved to be correct.

Yang Rui can eat it all his life. FDA or any country's GMP regulatory agency should pay attention to what he said.

Of course, it's not that Yang Rui said that GMP specifications will be modified if they are modified. However, it's also reasonable to include them in the discussion of the meeting and provide a complete set of documents to determine whether to modify or not.

In fact, GMP was originally developed by six American professors in the 1960s.

It was in the late 1970s that the United States determined it in the form of law and forced the major pharmaceutical companies to adopt it. Academically, Yang Rui is too qualified to question it.

Moreover, GMP is not static, it has two ways of change.

One is complicated and difficult, that is, to issue or modify the updated laws.

The other is relatively simple and commonly used by FDA, which is to issue guidance documents.It is relatively rare to change the law. It only happens once in a few years or even more than a decade. The guiding document is simple. Of course, the latter is not as effective as the former, and it is easy to be overturned by the court. However, in view of the fact that FDA is a powerful government department similar to China's in the medical industry, it is not likely that pharmaceutical enterprises will directly rebel. They have to do something about it, It's usually done before the document is issued.

A group of people are listening to Yang Rui.

In particular, the accompanying reporters invited by Huarui, greenstone corner and Jericho held up their cameras and tape recorders in a serious manner.

Looking around, Yang Rui pointed to the workshop on the other side of the glass and said: "our current GMP standard has made a variety of aseptic requirements for the workshop, but the aseptic level during the filling period still can not meet the actual demand. It's true that one millionth of the bacterial index is low enough, but for patients, one bacterial can be fatal, because our infusion products are ultimately used in weak patients. "

"I'm going to give you an example, Tyler capsule."

"Because of an inadvertent opening of the seal, the capsule was contaminated, resulting in the death of seven people Taylor capsule incident. It should be avoidable to adopt the correct mode of production. FDA's regulations on Anti-interference packaging are very good, but at the same time, we should also foresee that the risk of infusion products is higher than that of ordinary tablet products. "

Looking at the crowd, Yang Rui said directly, "the closed laminar flow device must be fully applied in GMP grade pharmaceutical factories, so as to ensure that the liquid medicine is always under the protection of nitrogen, so as to avoid oxidation contact and lax disinfection in the workshop. Similarly, the medicine bottle should also be evacuated and filled with nitrogen to ensure that the oxygen content is reduced to less than 1 / 10000, and the medicine bottle should be directly packaged... "

What Yang Rui said is actually the GMP standard published in the early 1990s, and this standard is naturally extracted from the dead - just like the aviation industry, every complicated standard in the medical industry, It's all about keeping more people alive.

However, in terms of the production level in the 1980s, nitrogen protection in the third level health workshop will not increase much cost.

The effect is extremely outstanding.

Reporters and some scholars have made records quickly.

This is not only a question, but also a solution. As long as the news gets out, the drug administration of any country can't take it lightly.

Including Chinese.

Some people who know something about the production of pharmaceutical factories even nod their heads, even some are fascinated.

Such an appropriate entry point is the right pace for high-level scholars to influence the world.

Scholars are not like politicians or businessmen. Their influence on the world has always been subtle, and they rely on at least the right thinking at that time as a fulcrum. If Yang Rui wants to influence the FDA and GMP of the Americans in the form of orders or money, it is very difficult to do so.

However, if he puts forward a valuable argument based on the correct thinking, it is difficult for the FDA of the United States to be unaffected. For a scholar, this is also the significance of exerting influence and value.

Furthermore, if the US FDA is affected, how should China's drug administration respond?

Those who think of this, especially the Chinese, can't help looking at Yang Rui.

Originally, the medical bribery Association, which was supposed to be just a simple and simple one, actually held a seminar and put forward such a big proposition.

Most of the reporters didn't know or care enough about the academic circles, but they were excited when they contacted the FDA and even the drug administration of more countries.

Someone looked at Yang Rui and raised his hand and said, "Mr. Yang Rui, do you mean that FDA and other drug regulatory agencies should build pharmaceutical factories based on Huarui pharmaceutical factory?"

Yang Rui took a look and found that he was a British reporter who came with Jericho. He said without too much scruples: "Huarui pharmaceutical factory is higher than the GMP standard, but when countries formulate the GMP standard, they should keep up with the high standard."

"Do you mean that the pharmaceutical factories in the United States and the United Kingdom should be similar to the Huarui pharmaceutical factory built in China?" The reporter has obviously entered the mode of picking things up.

However, Yang Rui didn't care about his choice. He said in English without hesitation: "China's Huarui pharmaceutical factory implements stricter and more effective standards. If the pharmaceutical factories in the United States and the United Kingdom can do so, I think more lives can be saved."

It's really hard for British journalists to answer the question of saving lives.

But Chinese journalists are writing hard.

……