Rebirth of the God-level Xueba

After lunch, they rested for another two hours. It was getting late before Huarui organized a visit to other parts of the pharmaceutical factory.

It is still the viewing passage, just take the other half way, from the second workshop to the first workshop.

Most people just took it as a cutscene and stopped watching carefully for a long time. Dr. Wang also followed lazily, like a teddy walking around, always trying to jump on something and shake his body twice.

In fact, there is no need for everyone to watch carefully. The standard of Huarui Pharmaceutical Factory has far exceeded the pharmaceutical factory that most people know. The British pharmaceutical factory that Dr. Wang highly recommends cannot keep up with the scale of Sinovel 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 started production. The machines purchased in advance will fall behind. In this case, whoever builds later will be the better pharmaceutical factory.

Of course, it is under the standard of gmp compliance.

Being able to achieve gmp compliance is not an easy task in itself.

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

What Wang Junhui didn't expect was that after Yang Rui said the words, a group of people really became energetic.

Wang Junhui was a little stunned, even a little annoyed, there were beauties standing in front of you, all of them seemed to be falling asleep, but when Yang Rui came out, you all woke up?

But she didn't understand that at least half of the people present today came because of Yang Rui.

The value of PCR increases with time. By the time of the 21st century, the invention of PCR has become as clear as a god—that is, in 1986, Yang Rui had only been in charge of PCR for more than two years, and Yang Rui's status had already reached the third level. jumped.

Scholars around the world generally recognize that Yang Rui is a second-tier scholar, especially in biology.

The first level is either those who have won the Nobel Prize, or the famous scholars with high reputation, and the second level is the scholars who have made the achievements of the Nobel Prize and are waiting to win the Nobel Prize.

Most of the second-tier scholars, the main reason for not getting the Nobel Prize is that they are too old and have not lived long enough to wait for the Nobel Prize.

Of course, the number of Nobel Prizes is limited, and new achievements 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 40 or 50 years. Live a little longer, and when he is eighty years old, he will not be able to get 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 the commentator said, but when Yang Rui spoke, he was completely different.

Dr. Wang immediately pricked up his ears.

How many times can a Nobel Prize-winning scholar speak in a lifetime?

Yang Rui did not use the microphone like Wang Junhui did, but said loudly in loud Chinese: "What you are seeing now is also a third-level sanitation area, and it is an area that has been inspected by me personally. I specifically request that I speak. It is because I hope that when the GMP specification is revised in the future, corresponding revisions can be made."

Yang Rui opened his mouth to revise the GMP regulations, but none of the scholars and doctors present felt that there was anything wrong.

The gmp specification is indeed the specification of the medical and health industry in the United States.

It is indeed a common norm in Europe and the United States, and it is indeed a norm that has been inspected by many administrators, scholars and legal professionals.

But so what?

If a second-level scholar in the world wants to revise your rules, you can only listen carefully.

Not to mention, Yang Rui also has a case of proving correct by independently resisting the laws and regulations.

Just this one thing, Yang Rui can eat it 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 discussion of the meeting, and a complete set of documents is given to determine whether to modify or not, which is also reasonable.

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

It became popular around the world when Americans legalized it in the late 1970s and forced major pharmaceutical companies to adopt it. Academically speaking, Yang Rui is too qualified to question it.

Furthermore, the gmp specification is not static, it has two ways of changing.

One is complex and difficult, that is, promulgating or revising updated laws and regulations.

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 is only produced once every 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 it is easy to be overturned by the court. However, given that the FDA is in the medical industry, It is a powerful government department similar to China. The chances of direct rebellion by pharmaceutical companies are not high. They have to do tricks, usually before the document is promulgated.

A group of people pricked up their ears, listening to Yang Rui's words.

In particular, the accompanying reporters invited by Huarui, Greenstone, and Zeneca held up their cameras and tape recorders with a serious look.

Yang Rui looked left and right, pointed to the workshop on the other side of the glass, and said: "Our current gmp specification has made various aseptic requirements for the workshop, but the degree of sterility during filling still cannot meet the actual requirements. Demand. Indeed, the bacteria index of one part per million is indeed low enough, but for patients, a single bacterium may be fatal, because our infusion products are ultimately used in weak patients .”

"I'll give you an example here, Taylor capsules."

"Just because of an inadvertently opened seal, the capsule was contaminated, and the Taylor capsule incident that resulted in the death of 7 people should be avoided by adopting the correct production method. FDA's regulations on tamper-proof packaging are very good, but at the same time , we should also see with foresight that the danger of infusion products is higher than that of ordinary tablet products.”

Looking at the crowd, Yang Rui gave the answer directly, saying: "The closed laminar flow device must be fully applied in the GMP-level pharmaceutical factory, so as to ensure that the liquid medicine 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 bottle should also be evacuated and filled with nitrogen to ensure that the oxygen content is reduced to less than one ten-thousandth, and it can be packaged directly..."

What Yang Rui said was actually the GMP specification of the first edition in the 1990s, and this specification was naturally extracted from dead people—just like the aviation industry, every complicated specification in the medical industry is designed to allow more people survived.

However, based on the production level in the 1980s, nitrogen protection in the third-level sanitary workshop would not increase the cost much.

The effect is extremely prominent.

Reporters and some scholars quickly took notes.

This is not only a question, but also a solution. As long as the news spreads, the drug regulatory agency of any country cannot take it lightly.

including Chinese ones.

some against pharmaceutical companies

Those who knew something about the factory's production nodded their heads even more, and were even fascinated.

Such an appropriate entry point is exactly 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, relying on at least the correct ideas at the time as a fulcrum. If Yang Rui wanted to influence the Americans in the form of orders or by throwing money at them, it would be very difficult to do.

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

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

People who think of this point, especially Chinese people who think of this point, can't help but look at Yang Rui.

What I thought was just a simple medical bribery meeting with eating, drinking and drinking turned out to be a seminar, and such a big proposition was put forward.

Most of the reporters did not know enough about or cared enough about the affairs of the academic world, but at this time they contacted the FDA, and even drug regulatory agencies in more countries, all of them became excited.

Someone watched Yang Rui finish speaking, then raised his hand and said, "Mr. Yang Rui, do you mean that the FDA and other drug regulatory agencies should use Huarui Pharmaceutical Factory as the standard to build pharmaceutical factories?"

Yang Rui glanced at it, and now he was a British reporter who came with Zeneca, so he said without too many scruples: "Sinovel pharmaceutical factory is higher than the GMP standard, but when countries formulate the GMP standard, they should follow the high standard. Come and see."

"You mean that the pharmaceutical factories in the United States and the United Kingdom should be on par with the Sinovel pharmaceutical factory built in China?" The reporter obviously entered the trouble-making mode.

Yang Rui didn't care about his provocation, and said in English without hesitation: "China's Huarui pharmaceutical factory implements stricter and more effective regulations. If the pharmaceutical factories in the United States and the United Kingdom can do this, I think it can save more lives. of."

When the proposition of saving lives came up, it was really difficult for British journalists to answer.

The Chinese journalists started writing furiously.

...

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