In pharmaceutical manufacturing, there are standards that may not always be visible, but must never be compromised. A single line of documentation, a single term, or one approval can be directly connected to patient safety. For more than 14 years, Kim Youngjin, Manufacturing Supervisor at LG Chem’s Life Sciences Division Iksan Plant, has reviewed and approved thousands of documents and processes, taking responsibility for the routine procedures that ensure medicines are produced safely.

In this interview, we spoke with Kim Youngjin about the role of a pharmaceutical manufacturing supervisor and why consistently adhering to fundamentals is essential in safeguarding drug quality and safety.

Q1. Hello! Please introduce yourself.

Kim Youngjin : Hello. I’m Kim Youngjin, and I work as a Manufacturing Supervisor at the Iksan Plant within LG Chem’s Life Sciences Division.

Q2. Why is it legally required to appoint a licensed pharmacist as a manufacturing supervisor, and how significant is that responsibility?

Kim Youngjin : The phrase “Medical treatment by doctors, medicines by pharmacists” reflects the intent to prevent misuse of pharmaceuticals and ensure their safe use. In line with this principle, the entire pharmaceutical life cycle—including manufacturing, quality control, import, distribution, and safety management—is regulated by law and must be overseen by licensed professionals such as pharmacists or physicians.

If a designated supervisor fails to fulfill their responsibilities and an issue occurs, it may lead to serious consequences, including license revocation or criminal liability. This clearly shows the weight of the responsibility that comes with the role.

Q3. How does pharmaceutical manufacturing management differ from general chemical manufacturing?

Kim Youngjin : Unlike general chemical products, pharmaceuticals cannot be manufactured at the discretion of the producer. Before production begins, manufacturing methods must be submitted and approved by the national regulatory authority and the Ministry of Food and Drug Safety (MFDS). Any changes to approved processes also require regulatory approval, depending on the nature of the change. In addition, pharmaceuticals can only be manufactured at facilities that have obtained GMP certification and meet legally defined facility standards.

*GMP (Good Manufacturing Practice): Standards for pharmaceutical manufacturing and quality management

Safeguarding Pharmaceutical Quality Through Documentation

Q4. We often hear that pharmaceutical manufacturing involves extensive documentation. How extensive is it?

Kim Youngjin : According to an internal company-wide review of standard document management, the Life Sciences Division has produced 44,534 documents—more than all other divisions combined.

One distinctive aspect of pharmaceutical manufacturing is real-time documentation. If the same adverse reaction occurs in multiple patients, traceability is essential to quickly identify the root cause and respond appropriately. For this reason, all events that occur during the production period are documented. Documentation is also the most effective way to demonstrate that a pharmaceutical plant is operating in compliance with GMP standards in real time. As a result, document management plays a critical role in pharmaceutical manufacturing.

Q5. What types of documents are managed by pharmacists?

Kim Youngjin : A representative document prepared at the plant for product approval is the Product Specification File. It includes basic product information, quantities of raw materials, manufacturing process flow diagrams, lists of production and quality control equipment, test standards and methods and manufacturing and packaging instructions and records. To ensure that pharmaceutical plants continue to operate in compliance with GMP regulations, internal guidelines such as GMP standards, site master files, and standard operating procedures are also maintained.

Final Approval and the Weight of Responsibility

Q6. As the final approver of manufacturing records, what do you pay the most attention to?

Kim Youngjin : I review and approve more than 2,400 documents each year, and I have been doing so for the past 14 years. During this process, pharmaceutical and GMP terminology can sometimes be confusing. therefore, I first check whether terms are used accurately and consistently and then verify if documents align with the latest regulations and approved product licenses.

While abbreviations or informal names may be used on-site for convenience, official documents must always use approved formal terminology. Because multiple people may revise a document over time, maintaining consistency and uniformity across all documents is an important part of my role. Since regulatory authorities can review these documents at any time, even small errors can affect the company’s credibility. I approach every review with that sense of responsibility in mind.

Q7. Do your responsibilities extend beyond documentation?

Kim Youngjin : Yes. Through the Korean Pharmaceutical Association, I receive information on cases where GMP violations resulted in administrative actions. I share relevant cases with all team leaders at our plant so they can serve as practical references.

I also conduct regular inspections of internal and external areas of the plant. When I identify gaps in GMP compliance, I communicate them to the relevant teams and request corrective actions. In addition, I manage the regular cleaning, drying, and distribution of cleanroom garments, cleanroom shoes, and lab coats worn by all personnel to maintain proper hygiene standards.

Steady Progress and Future Direction

Q8. Are there any experiences that you find particularly memorable or rewarding?

Kim Youngjin : Four experiences stand out.

First, early in my career, packaging unit labeling varied by product and export destination. By forming a task force with related departments, we conducted a comprehensive review and established guidelines, standardizing approximately 400 ERP master data records.

Second, there were cases where the same raw material was registered under different names across documents and systems. We revised raw material standards based on MFDS-approved ingredient names and updated related systems. Due to the scope, this process took about three and a half years.

Third, as the medical device business expanded, we separated documentation systems and approval lines for pharmaceuticals and medical devices, clearly defining authority and responsibility in accordance with relevant regulations.

Lastly, I conducted annual document-writing training sessions for all employees at the Iksan Plant over a five-year period. Despite the length of the sessions, participation and engagement were very high, which made the experience especially rewarding.

Q9. Have you faced any challenges in your role?

Kim Youngjin : Because my work does not directly translate into visible outcomes such as productivity or sales, it can only be evaluated qualitatively rather than quantitatively. In addition, since this is a legally designated role, there is no substitute when I am absent. Manufacturing instructions should be approved in real time based on production schedules, which makes it difficult to take extended leave.

Q10. Working with many departments across the plant, what principle do you value most?

Kim Youngjin : Among my colleagues, those who are known to work well also tend to write documents carefully and thoroughly. This applies not only to work, but to sports, arts, languages and academics as well. I believe the difference between being skilled and being truly exceptional lies in their grasp of fundamentals. A well-prepared document can build trust with regulatory authorities and ultimately, provide reassurance to the patients who rely on our medicines.

Q11. What are your goals moving forward?

Kim Youngjin : Until now, I have focused mainly on creating and managing documents, but going forward, I would like to pay more attention to retiring documents as well. Among the overwhelming volume of documents, I hope to contribute to more efficient document management by organizing and eliminating documents that are no longer valid – such as those related to decommissioned equipment or withdrawn product licenses – so that only valid information can be easily found.

Q12. Lastly, do you have a message for your colleagues?

Kim Youngjin : I would like to encourage all LG Chem employees who continue to fulfill their responsibilities quietly and diligently. Please take care of your health and thank you for your continued dedication.

Through this interview, we gained insight into the role and expertise that pharmaceutical manufacturing supervisors demonstrate on-site. Managing countless documents and processes while ensuring compliance with regulations and product approvals forms the foundation of pharmaceutical quality and safety.

Based on rigorous management across the entire pharmaceutical manufacturing process and experienced professionals, LG Chem is building an environment that patients and customers can trust. Moving forward, LG Chem will continue to deliver safe and reliable medicines based on its accumulated expertise in manufacturing and quality management.