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Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Quality control testing is inadequate in that the laboratory records did not include complete data Ultragenyx Pharmaceutical Inc. |
17 Sep 2026 | Normal | Justification: Environmental monitoring is directly linked as it ensures sterile conditions necessary for aseptic processing. Excerpt: The quality control laboratory failed to perform the required environmental monitoring during the aseptic filling process. View Details |
| Routine calibration, inspection and checking of automatic, mechanical and electronic equipment is not performed according to a written program RC Outsourcing, LLC |
03 Sep 2026 | Normal | Justification: The environmental monitoring process requires reliable equipment operation to ensure sample integrity and accurate data collection. Excerpt: Incubators and refrigerators used for product storage and EM sample incubation were not temperature mapped under loaded conditions. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process. RC Outsourcing, LLC |
03 Sep 2026 | Normal | Justification: Successful environmental monitoring is essential to ensure adequacy of aseptic conditions, which were deficient. Excerpt: In all three August 2025 video records covering both LFH and LFH no active air sampling was performed concurrent with the AFV studies. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process Imprimis NJOF, LLC |
18 Aug 2026 | Normal | Justification: Monitoring fails to provide adequate assurance of environmental control over the entire operation. Excerpt: The firm’s environmental monitoring program is inadequate. View Details |
| Appropriate controls are not exercised over computers or related systems Zydus Lifesciences Limited |
05 May 2026 | Normal | Justification: The process type of Environmental Monitoring is implicated as electronic data is not reviewed before batch release. Excerpt: Additionally, total air particulate environmental monitoring electronic data is not reviewed by Quality Assurance. View Details |
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