Samsung BioLogics achieves quality outcomes through the excellence in execution based on our Quality Management System (QMS).
Our QMS establishes the appropriate standards for the planning of quality
outcomes, executing the planned activities, the monitoring and measuring of
the results, analyzing the data, and correcting or improving those activities.
Samsung BioLogics’ Quality Unit functions independently from Operations. The role of the Quality and Compliance department is to ensure that all cGMP processes comply with the regulatory guidelines and requirements.
Our Quality Systems ensure that all equipment and systems are thoroughly maintained throughout cGMP production and our products are of the highest quality. The Quality and Compliance department provides accurate oversight of the release and / or rejection of raw materials, intermediates, products, packaging, and labeling materials, and the proper maintenance of critical equipment and instruments.
Quality and Compliance reviews and approves all Specifications, Standard Operating Procedures (SOPs) and Master Batch Records (MBRs) as well as conducts investigations for any product or facility related deviations. We have an established training program, which guarantees that any personnel involved in the cGMP operations are qualified to do so. In addition, a documentation management system is in place for the controlled generation, approval, and retention of all cGMP documents. In order to operate effective quality systems, scheduled periodic internal audits and management reviews are conducted.
Samsung BioLogics Quality & Compliance remains fully committed to the quality management that will produce continual improvements through the Corrective Action Preventive Action (CAPA) effectiveness checks and evaluation, quality risk assessments, our supplier audit program, an in-process management review, and the self-inspection program. Through the activities of our Quality & Compliance department, Samsung BioLogics maintains compliance with all international regulations for cGMP operations.
Samsung BioLogics (hereinafter, the “Company”) values users’ personal information, complies with statutory obligation s on protection of personal information such as the Act on Promotion of Information and Communication Network Utilization and Information Protection, etc. and the Act on Protection of Personal Information, and has created a Policy to Handle (Process) Personal Information to protect the users’ right and interest to the maximum extent possible.
Through the Policy to Handle (Process) Personal Information, the Company publicizes its operations on personal information treatment (processing) with particulars such as the types of personal information collected from the users and the purpose of processing such information, the time limit for processing and holding in possession, users’ method to exercise their rights, measures to procure the security, and so on.
Whenever there is a change in the Policy to Handle (Process) Personal Information, including updating, deleting, or adding its contents, whether resulting from any amendment to the relevant statutory sources or the administrative policy or change in the Company’s internal policy, we will post the change on our website at www.samsungbiologics. com so as to keep the users updated.
The Company’s Policy to Handle (Proce ss) Personal Information contains the following:
The Company collects personal information for the following purposes. The pfi will not be used for any other purpose and whenever it is necessary to change the purpose, we will comply with the statutory requirements such as obtaining users’ consents in advance.
Review and reply to the inquiries from users
Check employment history, give notices for future recruitment opportunities.
|Required||Name, Email Address, Company, Occupation, Country, Areas of Interest|
|Optional||Job Title, Phone Number|
The following information may be generated and collected in the course of using the service.
Access long, cookie
Collection through Contact Us, Talent Pool within the Website
Collection through generated information collection tool (for access long, cookie, etc.)
Personal information that needs to be collected and utilized inevitably as specifically required by law or regulations, or in order to comply with statutory requirements : As long as it is necessary to keep such information in possession under relevant statute.
Personal information that needs to be collected and utilized inevitably in order to execute and perform various contracts: Until the purpose of collection/utilization is accomplished.
Personal information collected and used with the consent of individual user: For the time period consented to.
If the user has given his/her consent in advance.
If it is specifically required by laws or regulations or inevitable in order to comply with statutory requirements, or if it is deemed necessary for the sake of life, body or property of the information owner or a third party when the information owner or his/her legal representative is under a state incapable of communication or unable to give consent due to unknown domiciles or otherwise (only to the extent the purpose of collecting personal information is served).
User’s personal information
History of the users personal information being utilized or provided to a third party
History of consents given to collection, utilization and provision of personal information
If it is specifically required by laws or regulations or inevitable in order to comply with statutory requirements.
If it is likely to jeopardize a person’s life or body or unjustly infringe a person’s property or other interests.
The Company is operating cookies that regularly stores and locates users’ information.
How to install cookies (if using Internet explorer 8.0) Select “Internet Option” in the “Tool”. Click “Privacy” tab. Using “Setting”, users may set the level of allowing cookies as suitable for their own needs.
How to view the cookie received (if using Internet explorer 8.0)
Select “Internet Option” in the “Tool”. Click “General” tab and select “Setting” of the Browsing History to check the files in “View Files”.
How to disallow cookie installation (if using Internet explorer 8.0) Select “Internet Option” in the “Tool”. Click “Privacy” tab. Using “Setting”, set it to the higher level, that is, “Block All Cookies”
in handling users’personal information, the Company endeavors to keep the personal information from being lost, stolen, revealed, tampered or damaged. To this end, the following technical and managerial actions are taken.
The Company implements its own internal management plan to secure safety in processing the personal information.
The Company is operating an internal organization dedicated to personal information protection to monitor the status of compliance with the personal information protective requirements and the responsible staff’s duty performance and takes corrective measures when any irregularity is found.
Installation and operation of access restriction device Using the intrusion blocking system, the Company controls any unauthorized access from outside and endeavors to procure all the technological system to the maximum extent feasible in order to secure systematic security.
Minimized designation of personal information processors and education The Company minimizes designation of personal information processors and implements internal and/or outsourced education on a regular basis. Personal information processors’ duty handover is conducted with the security fully maintained and their responsibilities for any personal information accident are clearly defined even after they have left the Company.
Restrictions on access to personal information The Company places restrictions on access to personal information through granting, changing or revoking the right to access to database system that processes personal information. We also record the history of granting, changing or revoking the right, which are retained for our records for at least three years.
The personal information of users is protected by the password and the file and transmission data are encrypted or stored by using file lock function. More important data are protected through certain separate security measures.
The Company has adopted security devices that enable safe transmission of personal information on the network using encryption algorithm.
To safeguard personal information from leak or loss by hackers or computer viruses, the Company has installed a security program and conducts periodic updating and reviewing.
For unmistakable security operation, every server is installed with intrusion blocking system as a means to block outsider intrusion by hacking as well as a system to analyze vulnerability.
To protect users’personal information and handle personal information-related customer complaint, the Company has appointed a personal information manager and processor. Any inquiry related to personal information protection and management should be directed to the personal information processor for instant and adequate reply.
Division: General Affairs Security Part, Personnel Management Team
Any user seeking to relief from personal information infringement may apply for resolution or consultation to Personal Information Dispute Mediation Committee, Korea Internet and Security Agency (Personal Information Grievance Center). In addition, users may contact the following institutions to be consulted on personal information infringement cases.
Personal Information Dispute Mediation Committee (118)
Korea Internet and Security Agency (Personal Information Grievance Center)(www.kopico.or.kr/1336)
Information Protection Mark Verification Committee (http://eprivacy.or.kr/02-580-0533~4)
Internet Crime Investigation Center of the Supreme Prosecutors’ Office
Cyber Police Agency (www.police.go.kr/1566-0112)
Personal information Protection Committee (http://privacy.kisa.or.kr/kor/main.jsp)/02-2180-3000)
When this ‘Policy to Handle (Process) Personal Information’ needs to be changed to reflect the change in statutory sources or government policies, we will put such change in public notice through an advisory statement and a separate window on the website.
Your valuable comments contribute to protecting Samsung Biologic’s core technology and management information, as well as reinforcing domestic competency and economic development.