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17
2025
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04
Lino People, Lino Heart (Series 7) | Exclusive Interview with QA Minister Li Ranran: Quality as Commitment, Ten Years of Tempering the "Quality Soul"
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Staff Style
2015 Years ago, a 22-year-old pharmacy intern walked into the LINO Pharmaceutical workshop, beginning her "ten-year appointment" with quality management. From the production line to the forefront of quality management, over 10 years, Li Ranran's growth trajectory has resonated with LINO Pharmaceutical's strategic upgrade. She says: "The mission of a quality person is to uphold the bottom line and break boundaries in every change."
From 'Light Chaser' to 'Light Bearer'
"When I first entered the workshop, my master told me that QA is the 'gatekeeper' of quality. Later, I understood that guarding the gate is not passive defense, but actively building a defense line."
2015 Years ago, Li Ranran started her career as an online QA, shuttling between production lines every day. From batch record review to supervision and inspection, from quality maintenance to process parameter monitoring, she "engraved" the GMP clauses into practical details.
"At that time, I followed the old masters to learn the process and focus on details every day. Every process must strictly comply with GMP regulations." She jokingly called this experience "a primer on quality awareness." With solid business skills and keen risk awareness, she was soon transferred to the validation management post, leading the completion of several key equipment validation projects, laying the foundation for subsequent GMP compliance.
2020 Year, 28 year-old Li Ranran became a young minister leading the QA team to overcome difficulties.
B Certificate campaign: pioneering in the "uncharted territory"
2023 Year, with the listing of the parent company, Koyun Pharmaceutical (stock code: 301281.SZ), LINO Pharmaceutical accelerated its product layout, and commissioned production and product introduction became strategic priorities. However, at that time, the company had no experience in B certificate application.
" "Previously, our system mainly served our own products. Now we need to deal with complex scenarios such as commissioned production and product introduction. It's like switching from a 'single-player game' to a 'network mode.'" She describes the challenges she faces in this way.
2024 At the beginning of the year, LINO Pharmaceutical's first commissioned production project—calcium benzenesulfonate capsules—B certificate application entered the countdown. As the QA head, under the guidance of the vice president of quality, Li Ranran led her team to adopt a "day and night" work model, "As the head of the QA team, I need to take the lead in many things. I have to be strong myself to lead the entire team to improve."
In just three months, this young QA team successfully obtained the first B certificate, laying a solid foundation for the subsequent application of a series of new products planned for listing.
The Long March of International Certification
With the launch of LINO Pharmaceutical's injection project, Li Ranran and her team once again faced a highly challenging task. The injection project aims to build a 4.0-era digital factory, built to EU and other international standards, and will be a "strong heart" for LINO Pharmaceutical to accelerate its internationalization.
"EU certification is our next goal, which requires us to achieve a qualitative leap in quality management." Li Ranran said, "We need to use international first-class standards to demand ourselves and protect LINO Pharmaceutical's journey to the world."
"Ten years ago, I learned from my master 'what is quality'. Now, I and my team together define 'what is LINO quality'—it is not only the bottom line of compliance but also the starting point of customer trust." Standing at a new starting point of development, Li Ranran and her team are drawing a more ambitious blueprint. "I hope that through our efforts, 'LINO quality' will become an industry benchmark, providing safer drugs for patients." This is Li Ranran's vision, and the common pursuit of all LINO quality personnel.
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