슬롯 머신

Once a champion of quality perfection, Samsung Biologics is now facing a setback. Following an inspection by the U.S. Food and Drug Administration (FDA), the company has been issued a '슬롯 머신 483.' The FDA's exceptional decision to disclose these findings on their official website has captured the attention of CDMO stakeholders both in South Koreaand internationally. HitNews delves into the three key points of contention outlined in the 슬롯 머신 483 issued to Samsung Biologics and explores their implications.

The 슬롯 머신 483 received by Samsung Biologics from the FDA begins by pointing out the inadequacy of data integrity (DI) in MSAT (Manufacturing Scientific Analytical Technology). MSATis the department responsible for various aspects of contract manufacturing, including pilot production, technology transfer, manufacturing, quality management, and process monitoring. Data generated by MSAT is used in part for the Certificate of Analysis (CoA) and in the approval process of contract products. The FDA has criticized Samsung Biologics for the "inadequate" manner in which data is managed in this department.

According to this 슬롯 머신 483, the test data produced by Samsung Biologics' MSAT had not undergone independent evaluation by a third party. Furthermore, it was revealed that within MSAT, administrator passwords were shared, data backups were insufficient, and audit trails were lacking.

Issues with data management within MSAT had previously been raised during client audits conducted on July 6 and September 1 in 2022. Notably, during a Samsung Biologics executive MSAT tour on September 14 of the same year, the 슬롯 머신 483 indicates instances of writing passwords on sticky notes and sticking them to computers, sharing of administrator passwords, and recording test results on uncontrolled spreadsheets.

슬롯 머신 Biologics' Quality Unit failed to revalidate testing equipment at the appropriate intervals, as pointed out by the FDA. The document mentions issues with six specific devices. For example, Device A was scheduled for revalidation on July 1, 2022, but the actual revalidation occurred approximately two months later on September 21. Devices B and C also experienced delays of around two months and one month, respectively.

Additionally, two high-per슬롯 머신ance liquid chromatography (HPLC) devices and enzyme-linked immunosorbent assay (ELISA) equipment had expired revalidation periods during the FDA inspection days in August and September. The 슬롯 머신 483 noted that these devices were still in use past their revalidation due dates.

The 슬롯 머신 identifiedinadequately maintained facilities and equipment during the inspection. First, in the "Grade B space," which should be maintained nearly aseptic, there was an issue with a dislodged ceiling port cover directly above the production plant. This condition was observed while setting up the filling line for a particular batch.

Furthermore, in the Solid Waste Collection facility, the lower part of a door leading to the outside was damaged, and it was noted that there was no dock seal in the area where materials are transported in the Office Supply facility. According to the 슬롯 머신, these deficiencies could serve as potential entry points for external contaminants.

The industry's response to Samsung Biologics receiving the 슬롯 머신 483 has been characterized by the notion of "surprising failure to meet basic standards." A high-ranking executive from a major South Korean pharmaceutical and biotech company commented, "Considering that around 80% of companies undergoing FDA inspections receive 슬롯 머신 483, the issuance of 슬롯 머신 483 itself is not a significant issue." However, the executivealso noted, "The issues pointed out in Samsung Biologics' 슬롯 머신 483 were very basic aspects that should be rigorously adhered to within GMP facilities."

The executive further commented, "Even if sharing administrator passwords or leaving them on Post-it notes may appear as simple oversights, they demonstrate a deficiency in fundamental internal management." They continued by expressing concern, stating, "The fact that basic issues like equipment revalidation and facility flaws were discovered unaddressed during the 슬롯 머신 inspection, which was anticipated, reveals internal systemic problems."

In response, Samsung Biologics emphasized that a 슬롯 머신 483 is a standard document issued in response to observations made during inspections. They stated that there were no significant flaws in their processes or insurmountable issues pointed out. A company representative said, "We will maintain ongoing communication with the FDA and our customers to promptly address the observations and prepare for improvements." They further added, "Receiving the 슬롯 머신 483 does not have any impact on product quality or patient safety, and we can confidently assure that."