After lunch, another two hours of rest, and it was already getting late, so Sinovel organized everyone to visit the rest of the pharmaceutical factory. Pen @ fun @ pavilion wWw. ｂｉｑUｇE。 ｉｎｆｏ

As usual, it is a visit passage, just take another half of the way, from the second workshop to the direction of the first workshop.

Most people just thought it was a cutscene and didn't watch it carefully, but Dr. Wang also followed lazily, like a teddy walking a corner, always trying 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 have far exceeded the pharmaceutical factories that most people understand. For example, the British pharmaceutical factory that Dr. Wang admires so much cannot catch up with the scale of Sinovel Pharmaceutical Factory - with the rapid development of the pharmaceutical industry in the 80s, the factory was newly built for two years, and it has not even been put into production, and the machines purchased in advance are about to fall behind.

Of course, under the standards of GMP compliance.

Achieving GMP compliance is not an easy task in itself.

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

What Wang Junhui didn't expect was that when Yang Rui came out of the two words, a group of people really got in good spirits.

Wang Junhui was a little stunned, and even a little angry, obviously there are beautiful women standing in front of you, all of them seem to be about to fall asleep, but Yang Rui came out, and you are awake?

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

The value of PCR is growing over time, and by the time of the 21st century, the invention of PCR has been a god-like invention - that is, in 86 years, Yang Rui invented PCR only for more than two years, and Yang Rui's own status has tripled.

Around the world, scholars basically recognize Yang Rui as a second-order scholar, especially within biology.

The first level is either a Nobel Prize, or a famous scholar with a high reputation, and the second level is a scholar who has made Nobel Prize achievements and is waiting to win the Nobel Prize.

The main reason why most second-order scholars do not 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 achievements emerge every year, and it is becoming more and more difficult to wait for the Nobel Prize, but a young man like Yang Rui can wait for at least forty or fifty years, and if he can live a little longer, when he is eighty years old, the Nobel Prize will not be given to him.

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

Many people don't care much about what the commentator says, but when Yang Rui opened his mouth, he was completely different.

Dr. Wang also immediately pricked up his ears.

How many times can a Nobel Prize-level scholar listen to a speech in a lifetime?

Yang Rui did not use the microphone like Wang Junhui, but used loud Chinese and said aloud: "What you see now is the same third-level health area, which has been personally inspected by me, and I specifically request that it be said by myself, because I hope that when the GMP specification is revised in the future, it can be revised accordingly." ”

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

The GMP norm is indeed the norm of the medical and health industry in the United States, and it is indeed the norm that is common in Europe and the United States, and it is indeed the norm that has been examined by many administrators, scholars and legal professionals.

But so what?

A scholar of the second order of the world, if you open your mouth to fix your norms, you can only listen attentively.

Not to mention, Yang Rui also has a case of proving the right thing by resisting the law alone.

Just this one thing, Yang Rui can eat for a lifetime. The FDA, or any country's GMP authority, has to listen to what he has to say.

Of course, it is not that Yang Rui said that if it is modified, the GMP specification will be modified, but it is also natural to include it in the discussion of the meeting for this reason, and give a complete set of documents to determine whether to modify or not to modify.

In fact, the GMP specification was originally developed by six American professors in the 60s.

Its adoption was only in the late 70s, when the Americans established it in the form of a law and forced major pharmaceutical companies to adopt it, which swept the world. Academically, Yang Rui is too qualified to question it.

Furthermore, the GMP specification is not static, it can change in two ways.

One is complex and difficult, that is, the issuance or modification of updated decrees.

The other is relatively simple, and is commonly used by the FDA, which is to issue guidance documents.

Of course, the latter is not as effective as the former, and it is easy to be overturned by the court, but given that the FDA is a powerful government department similar to China in the medical industry, it is unlikely that pharmaceutical companies will directly rebel, and they will do it before the document is issued.

A group of people pricked up their ears and listened to Yang Rui speak.

In particular, the accompanying reporters invited by Sinovel, Greenstone Corner and Jielikang raised their cameras and tape recorders, looking serious.

Yang Rui looked left and right, pointed to the workshop on the other side of the glass in a very stylish way, and said: "Our current GMP specifications have made a variety of aseptic requirements for the workshop, but the degree of sterility during filling still cannot meet the actual needs. It is true that the bacterial index of one part per million is indeed low enough, but for patients, a single bacterium can be fatal, because our infusion products are ultimately applied to weak patients. ”

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

"The Taylor capsule incident, which resulted in the death of seven people due to the contamination of the capsule due to an inadvertent opening of the seal, should have been avoided with the right production methods. FDA's regulations on tamper-proof packaging are good, but at the same time, we should also have foresight to see that infusion products are more dangerous than ordinary tablet products. ”

Looking at everyone, Yang Rui directly said the answer and said: "The closed laminar flow device must be fully applied to the GMP-level pharmaceutical factory, so as to ensure that the liquid medicine is always under the protection of nitrogen, not only to avoid oxidation contact, but also to avoid poor disinfection in the workshop." Similarly, the vials should be pumped out to be filled with nitrogen to ensure that the oxygen content is reduced to less than 1 part per 10,000, and packaged directly......"

What Yang Rui said is actually the first version of the GMP specification in the 90s, and this specification is naturally refined from dead people - just like the aviation industry, every complicated specification of the medical industry is to allow more people to survive.

At the level of production in the 80s, nitrogen protection in the sanitary three-level workshop will not increase the cost much.

The effect is extremely outstanding.

Journalists and some scholars are quick to take notes.

This is not only a problem, but also a solution, as long as the news spreads, no country's drug administration can afford to ignore it.

Including Chinese.

Some people who know something about the production of pharmaceutical factories nodded their heads again and again, and even some were fascinated.

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

Scholars are not like politicians or businessmen, they have always influenced the world subtly, relying on at least the right ideas of the time to act as a fulcrum. If Yang Rui wants to influence the FDA and GMP of the Americans in the form of orders or throwing a lot of money, it will be very difficult to do.

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

Further, if the FDA in the United States is affected, how should China's drug regulatory agencies react?

People who thought of this, especially the Chinese who thought of this, couldn't help but look at Yang Rui.

originally thought that it was just a simple, eating and drinking medical bribery meeting, but it really became a seminar, and it put forward such a big proposition.

Most of the reporters don't know enough about the academic world, or don't care enough about it, but at this time, when they contact the FDA and even more countries' drug regulatory agencies, they are all excited.

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

Yang Rui glanced at it and found that it was a British reporter who came with Jielikang, so he didn't have too many scruples and said: "Huarui Pharmaceutical Factory is higher than the GMP standard, but when countries formulate GMP specifications, they should be on par with high standards." ”

"Do you mean that the pharmaceutical factories in the United States and Britain should be on par with the Huarui pharmaceutical factories built in China?"

Yang Rui didn't care about him provoking trouble, and said in English without hesitation: "China's Huarui pharmaceutical factories have implemented stricter and more effective regulations, and if the pharmaceutical factories in the United States and the United Kingdom can do this, I think more lives can be saved." ”

When the proposition of saving lives came out, British journalists really couldn't take it.

Chinese journalists, however, struggled to write.

……

Shitori Village said

On Chinese New Year's Eve, Big Bird Boy greets you!

I wish you great health, family happiness and all the best.