Sustainability
A global pioneer in the development of new drugs
Product Safety & Quality
To reinvigorate our customers’ life and realize their good health and safety,
SK Biopharmaceuticals will always endeavors to improve its Quality Management System (QMS)
to a global level, retain responsibility and trust as a global pharmaceutical company, and
sustain an unflagging and thorough quality management.
Management
SK Biopharmaceuticals and its subsidiary, SK Life Science, prioritize the quality management of products
and investigational drugs under a Harmonized Global Quality Policy to ensure efficacy and safety of products.
Operating a Quality Management System (QMS), we conduct continuous monitoring of quality incident, drug surveillance,
and quality and safety management training.
Furthermore, we are building a top-level global quality management system by digitalizing of quality management system.
Targets
Achieve zero product quality and safety related incidents.
-
0
Achieve zero recalls or violations
regarding product safety
(Zero in the year 2021-2023) -
0
Achieve zero violations of complying
with the regulations for timely
reporting of drug safety
(Zero in the year 2021-2023)
Performances
Quality Test Management
SK Biopharmaceuticals performs quality testing thoroughly on all product batches under the strict Quality Management System (QMS) in compliance with international regulations to ensure that only acceptable batches with product specifications are released in the markets. Product quality testing is conducted through the GMP QC Lab of Contract Manufacturing Organizations (CMOs), and the QC Lab is validated and controlled through periodic on-site inspections. In addition, Annual Product Quality Review, Continuous Process Verification, and Stability Testing are performed every year to prevent risk factors of product safety and quality in advance, and based on the analyzed results, the product quality level has been continuously improved.| Batch Release Test |
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| Annual Product Quality Review |
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| Continuous Process Verification |
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| Stability Test |
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Quality Management Training
All employees involved in activities related to product quality and safety receive training on job requirements according to internal policies based on the Good x Practice (GxP), and SK Life Science supports additional job-related external training courses once a year.In addition, SK Life Science conducts internal and partner audits to periodically monitor the implementation of the training programs.
Safety & Quality Training for Supply Chain
SK Biopharmaceuticals annually provides safety & quality-related training for its suppliers in all value chains.By hosting external trainers and offering ISO (International Organization for Standardization) 9001 and GMP (Good Manufacturing Practice)-based training, we strive to prevent any negative event of safety and quality potentially occurring from supply chain.
Employee Training on Responsible Marketing & Advertising Practices
All the employees are automatically assigned to SK Life Science’s Learning Management System, ComplianceWire, and are required to complete compliance-related training via such system. In 2022, five training courses on responsible marketing and advertising practices were provided in total with in-depth coverage of the below topics.| No. | Training Topic |
|---|---|
| 1 | Code of Conduct |
| 2 | Commercial Field Compliance Manual |
| 3 | Copy Review Committee |
| 4 | Healthcare Professional Interactions |
| 5 | Patient & Patient Organization Interactions Policy |
Internal Controls for Responsible Marketing
SK Life Science, a wholly owned subsidiary of SK Biopharmaceuticals, maintains internal policies for responsible marketing and the policies are reviewed by the Promotional Material Review Committee (“PMRC”) to ensure compliance with both company policies, applicable laws and regulations, the Pharmaceutical Research and Manufacturers of America (PhRMA) Code and consistency with the product label.In particular, all sales representatives are strictly required to return all expired or withdrawn materials, and SK Life Science periodically checks that its sales representatives only have current printed materials and informs the representatives of updated materials immediately through digital materials.
SK Life Science also uses external speakers as part of speaker programs and has policies and trainings for these speakers on how to conduct compliant speaker events. As part of the compliance auditing, SK Life Science does in-person compliance attendance at a percentage of these events each year and conducts reviews of the speaker program, rates being paid, appropriate materials being used, and does sampling of the speaker program documentation to audit and ensure the programs are being run compliantly.
In addition, SK Life Science maintains a policy regarding limits on meals associated with sales presentations and does sample those transactions and conducts reviews of its product sampling program to ensure compliance with the policies.
[ SK Life Science’s Policies and Standard Operating Procedure for Responsible Marketing ]