Ostem Pharma is accelerating the expansion of its contract manufacturing organization (CMO) business while proactively ensuring data integrity. The company leverages its experience in producing and supplying its own pharmaceutical products, along with advanced manufacturing infrastructure, to embed the regulatory requirement of quality integrity into its digital systems.
On May 21, Ostem Pharma announced that it is strengthening its production infrastructure and quality management systems at its pharmaceutical manufacturing facility in Osong, North Chungcheong Province. The company has developed and produced dental anesthetics, antibiotics, and anti-inflammatory drugs, accumulating quality management expertise, and has proactively secured data integrity (DI), which has become increasingly important in the pharmaceutical industry.
Data integrity refers to the preservation of original data generated during the pharmaceutical manufacturing process, ensuring that it remains unaltered and free from manipulation or omissions. In the pharmaceutical sector, DI is considered a critical indicator of drug safety and efficacy, as well as a key measure of customer trust.
Ostem Pharma has connected all processes from raw material receipt to finished product shipment through a digital quality management system, applying designs that prevent data manipulation and omissions to enhance the reliability of the manufacturing process. The company is also refining its quality assurance (QA) and quality control (QC) systems to improve both production efficiency and quality, focusing on minimizing regulatory and supply risks for its clients.
Additionally, Ostem Pharma plans to pursue approval for essential medicines that are often subject to supply instability, particularly pain relievers. If successful, the company anticipates securing approval for pain relief ingredients by next year, contributing to the pharmaceutical supply chain.
As certain ingredients, such as pain relievers, are linked to supply instability, it is crucial for domestic pharmaceutical companies to establish backup production capabilities. This not only ensures continuity in healthcare delivery but also aligns with the government's policies on stable pharmaceutical supply.
Concerns have grown in the market as commonly used prescription medications, including pain relievers, cold medicines, and laxatives, have repeatedly faced shortages. According to data from the Ministry of Food and Drug Safety, there were 147 reports of supply interruptions for designated essential medicines from 2020 to August of last year. A total of 473 items have been identified as essential medicines.
An Ostem Pharma representative stated, "Our manufacturing competitiveness is based on rigorous quality management capabilities. We aim to position ourselves as a business partner that can enhance both cost competitiveness and quality for our clients."
* This article has been translated by AI.
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