발간보고서
home > 자료실> 발간보고서
- 글자크기
Korean Pharmaceutical/Biotech companies gaining access to the US Markets by working with United Stat
| 작성자 | 관리자 | 카테고리 | 전문가 인사이트 |
|---|---|---|---|
| 작성일 | 2016-05-25 | 조회수 | 1,553 |
| 원문 | |||
| 출처 | |||
Korean Pharmaceutical/Biotech companies gaining access to the US Markets by working with United States Contract Manufacturing Organizations
- 글 Christopher McBride
- GPKOL 위원
상임 컨설턴트
컨설팅 분야
- 상품 출시 과정의 CMO 활동 감동
- 추가 CMO 선별을 통한 상품 출시 지원
- 계약생산대행 및 Disposable Technology
주요 약력
- 2014-현재 Omnia Biological, Project Management Director
- 2012-2014 Insmed, External Manufacturing Manager
- 2010-2011 Pall Corporation, Global Project Manager
- 2007-2010 Thermo Fisher Scientific Logan, Technical Service Manager
Ⅰ. 서론(Introduction)
Omnia Biologicals
Most Pharmaceutical companies have a business need to gain access to markets around the world for their products to be sold in. The global market is divided into several Regulatory Authorities that govern the manufacture of products in their domain. In the US, we have the FDA.
Ⅱ. 본론(Main Subject)
The FDA should be used as an asset to guide any Korean Companies on the specifics of what their expectations are in regard to discovery, lab scale development work, Clinical production/testing (Phases 1-3), manufacturing of launch material and Commercial manufacturing. I will describe the processes that I have been involved with over my 30 plus years in the Pharmaceutical/Biotech business. If it is the goal of a South Korean company to introduce their product into the US market, it would be advisable to hire US Contract Manufacturing Organization.
If it is the goal of a South Korean company to introduce their product into the US market, it would be advisable to hire US Contract Manufacturing Organization. While selecting a Contract Manufacturing Organization, ensure that when you audit the facility, that you look at the storage capacity in refrigerators and controlled vaults to ensure that they are in compliance in terms of segregation and labeling. Some Contract Organizations have a tendency to take on more projects than they are capable of processing in the confines of their facility. Review their personnel and equipment flow procedures to ensure that their procedures make good sense in terms of product personnel and product flow.
Examples of what to look for are product flow that requires an elevator, is the elevator a freight elevator that is designed to move product or is it a passenger elevator that is being used as a freight elevator. This would be a sign that the facility has some constraints. Look at the type of carts that are being used to transport product. Ensure that sturdy (ie. Metro), enclosed carts are being utilized as opposed to open plastic carts. Check deviations that pertain to loss of finished product as a result of using deficient carts where product falls off the cart during transport or staging. Check open maintenance repair/improvement projects to ensure that they are initiated promptly. This will tell you that the CMO is serious about process improvements and not just kicking the can down the road (delaying the project). Check the QA presence and communication on the floor. Does the CMO have QA representation on the floor and raising QA issues properly throughout the organization? This will tell you that QA an important part of the manufacturing process and not just responsible for reviewing batch records (getting the product out the door. You should also check the ration between the filling staff compared to the Inspection group. If they have two Filling shifts/operations and one Inspection team, then you know there is going to be a bottleneck. Another thing to ask a CMO for is an example of a batch of product that was put on hold. This will show you how robust their Quality System is. If they cannot show you examples and the communication throughout the operations team and Quality, then they are weak in this area and a potential for product mix up is high. Training is an important aspect of Quality that needs to be looked at. Check that QA is involved in deciding when an employee is deemed trained. Ensure that the CMO does not have a read and understand training program that leaves the training on the operators. This shows that management is only concerned with getting the product out the door and being short sided on Quality.
Ⅲ. 결론 및 시사점(conclusion)
In conclusion, a Korean company that wants to partner with a US CMO as a means of entering the US market must perform due diligence and dig deep into the CMO’s systems to ensure that they align with a CMO that has a strong commitment to a Quality system that will be able to help them perform all the activities to sell product in the US regulated market.
- 이전글 이전글이 없습니다.
- 다음글 다음글이 없습니다.
