Quality issues alarmed the pharmaceutical industry

not optional but essential

There are many opinions in the pharmaceutical industry to self-purify, and the association operates innovative TFs

QbD and data completion' is urgently needed

Recent cases of GMP violations by Korean pharmaceutical companies have served as an opportunity to guard against risks throughout the industry.

 

In addition, there are opinions that it should be improved in the wake of this incident.

 

Until now, actual changes in standards for GMP have been sluggish according to global level.

 

Only a few companies aiming to expand overseas have voluntarily attempted to improve.

 

Looking at the recent cases, most small and medium-sized companies have been commissioned to produce pharmaceutical drugs to the domestic market, but even large companies, which are consignment companies, cannot avoid responsibility.

 

The consignee lacked quality control, and the trustee had to meet the customer's needs.

 

What efforts are being made in the industry?

 

Dailypharm held the 42nd Future Forum under the theme of 'KGMP Ethics and Compliance!

 

How to Lead' on the 16th and listened to industry opinions.

 

Professor Lee Jae-hyun of Sungkyunkwan University is the head of the group, Lee Sam-soo, CEO of Boryung, Chung Myung-hoon, deputy director of the MFDS' drug quality management department, and Kim Eun-young, CEO of Waters Korea, attended the panel to express their opinions.

 

From the left, Lee Jae-hyun, professor at SKKU, Lee Sam-soo, CEO of Boryㅕng, Chung Myung-hoon, director of the MFDS, and Kim Eun-young, CEO of Waters Korea

Labor shortages, lack of technology, and lack of awareness are the causes of the situation CEO Lee Sam-soo analyzed that both environmental and technical factors played a role in the frequent occurrence of drug quality problems.

 

According to him, there were 477 pharmaceutical manufacturers in South Korea as of 2019, and each manufacturer produced ₩49.9 billion.

 

Among them, the average of the bottom 80% is only ₩189 billion.

 

More than 100 finished drugs are owned per company.

 

There was a huge shortage of manpower per plant.

 

There are about 500 factory managers that should be mandatory, and 500 QM and manufacturing managers are also needed.

 

The generic licensing process is also easier than that of advanced countries.

 

CEO Lee said, "In the U.S.

 

and Europe, generics should also have all CTD (Common Technical Document) formats, but in Korea, drugs for data-based re-evaluation are only required." There was a lack of research on quality factors or processes to be considered from the product design stage, consideration of subtle changes that occur while scaling up, and reflection of changes in pharmaceuticals, standards, and equipment.

 

"Let's restore confidence in pharmaceuticals." No matter how important quality management is, it is useless without the will of management.

 

Therefore, the new Drug Quality Management Innovation TF, which was established at the KPBMA, is noteworthy.

 

The TF will be joined by Lee Sam-soo, CEO of Boryung, Kwon Ki-beom, vice-chairman of Dongkoo, Ildong's CEO Yoon Woong-seop, and Huons Global vice-chairman Yoon Sung-tae, and Hee-mok Won, chairman of the KPBMA.

 

The team is based on owners and representative directors who can make decisions.

 

The main role of TF is to identify each company's permission and cases of non-compliance with GMP, analyze the causes, and present solutions.

 

It will also find matters that need to be improved.

 

It also has a working group of TF that focuses on GMP experts from 15 businesses such as factory manager, QM manager, and research institute head.

 

They listen to the field's opinions and share their opinions with the MFDS.

 

Industries are actively supporting amendments to 1+3 Pharmaceutical Act by actually operating TF.

 

The industry agreed with the MFDS that the introduction of Quality by Design (QbD) and data integrity should be emphasized to improve quality control.

 

The purpose of the TF is to achieve various education, meetings, information sharing, and system improvement to realize these goals.

 

CEO Lee said, "We intend to expand human resources education by opening online seminars and curricula of the association, visit each other among manufacturing plants, and share data." "We will also achieve quantitative and qualitative improvements by supplementing QA/QC personnel and supporting regular training." In order to spread the introduction of QbD, it should be accompanied by support measures.

 

QbD, the industry believes that carrot-and-stick policies are needed to achieve a common goal of data completeness.

 

CEO Lee said, "QbD is key to both risk assessment and statistics, and in order to become a smart factory, auxiliary tools such as PAT must be applied together." Real-time analysis does not follow simply by doing QbD.

 

"It will cost tens of billions of won to install analysis equipment and sensors for auxiliary tools, so it will not be easy to introduce unless it is a blockbuster item." As a result, industries are strengthening regulations on quality management while also requesting support measures.

 

It applies tax benefits for facilities/equipment necessary for QbD or data completeness, rapid review of related items, and preferential treatment of drug prices.

 

"We will discuss with innovative TFs and actively consider operating a developmental GMP system," said Chung Myung-hoon, an official who attended as a representative of the MFDS.

 

"We will listen to various opinions such as difficulties of small and medium-sized companies so that we can actively improve the constitution of the industry."