Volume 31 previews Connexo’s presentation at Honeywell Life Sciences World Tour Korea and looks at environmental monitoring and cleaning validation. Regulatory coverage includes two FDA warning letters and a treatment approval.
Connexo at HLS Korea
Connexo will participate as a sponsor and speaker at the Honeywell Life Sciences World Tour Korea on August 21, 2025, at the Enfold Hotel in Cheongju. The event runs from 9:00 a.m. to 1:10 p.m.; Connexo’s service and support session is scheduled for 12:00–12:20 p.m.
The presentation will cover TrackWise implementation experience and approaches to visualizing and analyzing quality data. The wider program includes quality and recall management, AI-assisted decisions, manufacturing risk, and developments in TrackWise and TrackWise Digital.
Environmental monitoring and air-sampling records
Novatek Environmental Monitoring manages sampling plans and records for air, surfaces, and water. Its integration with MAS-100 NT air samplers supports the transfer of sampling information between the instrument and the software, reducing manual transcription. Microbial culture results are assessed after incubation; the integration does not provide an immediate microbial count.
The system supports location-based trending, alerts, deviation records, and audit trails. These functions help teams investigate results and maintain traceability across sampling and review activities.
Read Novatek’s description of the MAS-100 NT integration.
Cleaning validation records
Novatek’s cleaning validation software brings plans, procedures, analytical results, and qualification history into one system. Retest alerts, risk-based scheduling, approval workflows, and electronic signatures support the work that is otherwise often tracked across spreadsheets and separate documents.
Reports can be organized by equipment, product, or process. The aim is to make the validation history easier to follow and reduce gaps in recordkeeping and review.
FDA warning letters: Daewoo and Glenmark
The FDA’s amended warning letter to Daewoo Pharmaceutical, dated July 2, 2025, followed an inspection of its Busan facility from January 6 to 15. The agency cited weaknesses in smoke studies, media fills, aseptic practices, and personnel and environmental monitoring. It requested risk assessments and a detailed remediation plan.
Read the Daewoo warning letter.
In its July 11, 2025 warning letter to Glenmark Pharmaceuticals, the FDA raised concerns about investigations of out-of-specification results and manufacturing controls at the Pithampur facility in India. The letter also addressed recurring problems across the company’s sites and called for broader corrective action.
Read the Glenmark warning letter.
FDA approves Qfitlia
On March 28, 2025, the FDA approved Qfitlia (fitusiran) to prevent or reduce bleeding episodes in patients aged 12 and older with hemophilia A or B, with or without factor inhibitors. The treatment lowers antithrombin activity and can be administered by subcutaneous injection up to once every two months.
The approval includes boxed warnings for thrombotic events and gallbladder disease. The FDA also identified liver toxicity as a risk and described monthly liver testing during the first six months of treatment.
Read the FDA approval announcement.
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