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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 |
|---|---|---|---|
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile Eugia Pharma Specialities Limited |
06 Feb 2026 | Normal | Justification: Contamination control is critical in aseptic operations and interventions disruption in airflow can lead to contamination. Excerpt: rely on a (b) (4) wait time for NVPC to return to normal without validated recovery times. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed Eugia Pharma Specialities Limited |
06 Feb 2026 | Normal | Justification: The observation details lapses in sterile practices (e.g., contact with sterile equipment), directly implicating contamination control procedures. Excerpt: Poor aseptic practices and inadequate glove monitoring were observed during review of CCTV recordings of sterile production. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. Sato Pharmaceutical Co., Ltd. |
05 Jan 2026 | Normal | Justification: The observation highlights flaws in controlling contamination due to inadequate airflow studies and equipment setup. Excerpt: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy |
19 Dec 2025 | Normal | Justification: Failures in contamination control processes seen in environmental monitoring excursions and lack of follow-ups. Excerpt: Unacceptable microorganism concentrations were reported... No root cause or corrective actions and preventative actions were documented. View Details |
| Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not appropriate for the duties they perform. JKR Pharmacy Ventures, LLC dba Doc Lane's Veterinary Pharmacy |
19 Dec 2025 | Normal | Justification: The inadequate attire observed impacts contamination control in sterile settings, exposing drug products to contamination risks. Excerpt: Your firm's pharmacy technicians...don scrubs worn from home, a disposable non-sterile gown, a single non-sterile hair net... View Details |
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