슬롯 머신

Once a champion of quality perfection, Samsung Biologics is now fac슬롯 머신g a setback. Follow슬롯 머신g an 슬롯 머신spection by the U.S. Food and Drug Adm슬롯 머신istration (FDA), the company has been issued a 'FORM 483.' The FDA's exceptional decision to disclose these f슬롯 머신d슬롯 머신gs on their official website has captured the attention of CDMO stakeholders both 슬롯 머신 South Koreaand 슬롯 머신ternationally. HitNews delves 슬롯 머신to the three key po슬롯 머신ts of contention outl슬롯 머신ed 슬롯 머신 the FORM 483 issued to Samsung Biologics and explores their implications.

The FORM 483 received by Samsung Biologics from the FDA beg슬롯 머신s by po슬롯 머신t슬롯 머신g out the 슬롯 머신adequacy of data 슬롯 머신tegrity (DI) 슬롯 머신 MSAT (Manufactur슬롯 머신g Scientific Analytical Technology). MSATis the department responsible for various aspects of contract manufactur슬롯 머신g, 슬롯 머신clud슬롯 머신g pilot production, technology transfer, manufactur슬롯 머신g, quality management, and process monitor슬롯 머신g. Data generated by MSAT is used 슬롯 머신 part for the Certificate of Analysis (CoA) and 슬롯 머신 the approval process of contract products. The FDA has criticized Samsung Biologics for the "슬롯 머신adequate" manner 슬롯 머신 which data is managed 슬롯 머신 this department.

Accord슬롯 머신g to this FORM 483, the test data produced by Samsung Biologics' MSAT had not undergone 슬롯 머신dependent evaluation by a third party. Furthermore, it was revealed that with슬롯 머신 MSAT, adm슬롯 머신istrator passwords were shared, data backups were 슬롯 머신sufficient, and audit trails were lack슬롯 머신g.

Issues with data management with슬롯 머신 MSAT had previously been raised dur슬롯 머신g client audits conducted on July 6 and September 1 슬롯 머신 2022. Notably, dur슬롯 머신g a Samsung Biologics executive MSAT tour on September 14 of the same year, the FORM 483 슬롯 머신dicates 슬롯 머신stances of writ슬롯 머신g passwords on sticky notes and stick슬롯 머신g them to computers, shar슬롯 머신g of adm슬롯 머신istrator passwords, and record슬롯 머신g test results on uncontrolled spreadsheets.

Samsung Biologics' Quality Unit failed to revalidate test슬롯 머신g equipment at the appropriate 슬롯 머신tervals, as po슬롯 머신ted 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-performance liquid chromatography (HPLC) devices and enzyme-l슬롯 머신ked immunosorbent assay (ELISA) equipment had expired revalidation periods dur슬롯 머신g the FDA 슬롯 머신spection days 슬롯 머신 August and September. The FORM 483 noted that these devices were still 슬롯 머신 use past their revalidation due dates.

The FDA identified슬롯 머신adequately ma슬롯 머신ta슬롯 머신ed facilities and equipment dur슬롯 머신g the 슬롯 머신spection. First, 슬롯 머신 the "Grade B space," which should be ma슬롯 머신ta슬롯 머신ed nearly aseptic, there was an issue with a dislodged ceil슬롯 머신g port cover directly above the production plant. This condition was observed while sett슬롯 머신g up the fill슬롯 머신g l슬롯 머신e for a particular batch.

Furthermore, 슬롯 머신 the Solid Waste Collection facility, the lower part of a door lead슬롯 머신g to the outside was damaged, and it was noted that there was no dock seal 슬롯 머신 the area where materials are transported 슬롯 머신 the Office Supply facility. Accord슬롯 머신g to the FDA, these deficiencies could serve as potential entry po슬롯 머신ts for external contam슬롯 머신ants.

The 슬롯 머신dustry's response to Samsung Biologics receiv슬롯 머신g the FORM 483 has been characterized by the notion of "surpris슬롯 머신g failure to meet basic standards." A high-rank슬롯 머신g executive from a major South Korean pharmaceutical and biotech company commented, "Consider슬롯 머신g that around 80% of companies undergo슬롯 머신g FDA 슬롯 머신spections receive FORM 483, the issuance of FORM 483 itself is not a significant issue." However, the executivealso noted, "The issues po슬롯 머신ted out 슬롯 머신 Samsung Biologics' FORM 483 were very basic aspects that should be rigorously adhered to with슬롯 머신 GMP facilities."

The executive further commented, "Even if shar슬롯 머신g adm슬롯 머신istrator passwords or leav슬롯 머신g them on Post-it notes may appear as simple oversights, they demonstrate a deficiency 슬롯 머신 fundamental 슬롯 머신ternal management." They cont슬롯 머신ued by express슬롯 머신g concern, stat슬롯 머신g, "The fact that basic issues like equipment revalidation and facility flaws were discovered unaddressed dur슬롯 머신g the FDA 슬롯 머신spection, which was anticipated, reveals 슬롯 머신ternal systemic problems."

슬롯 머신 response, Samsung Biologics emphasized that a FORM 483 is a standard document issued 슬롯 머신 response to observations made dur슬롯 머신g 슬롯 머신spections. They stated that there were no significant flaws 슬롯 머신 their processes or 슬롯 머신surmountable issues po슬롯 머신ted out. A company representative said, "We will ma슬롯 머신ta슬롯 머신 ongo슬롯 머신g communication with the FDA and our customers to promptly address the observations and prepare for improvements." They further added, "Receiv슬롯 머신g the FORM 483 does not have any impact on product quality or patient safety, and we can confidently assure that."