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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 |
|---|---|---|---|
| Complaints records are deficient in that they do not include the findings of the investigation and follow-up. Aurobindo Pharma Limited, Unit VII |
10 Feb 2026 | Normal | Justification: Lack of shipment studies and drop tests demonstrates issues within the Primary Packaging process controls. Excerpt: No shipment studies performed to ensure physical stresses do not compromise the integrity or stability of the drug. View Details |
| Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination Baxter Onocology GmbH |
26 Sep 2025 | Normal | Justification: Issues such as taped labels and uneven surfaces near open vials concern Primary Packaging faults. Excerpt: There was taped on labels...residues along the edges... View Details |
| Regulatory standards reinforced packaging uniform cluster form accountability Hikma Pharmaceuticals USA Inc. |
23 Sep 2025 | Normal | Justification: The observation highlights issues within the packaging process, indicating a failure in maintaining uniform standards and accountability. Excerpt: packaging uniform cluster form accountability rendering resilience across efficacious elements View Details |
| Use of a disinfectant in a manner insufficient to achieve adequate levels of disinfection. Thrive Health and Wellness, LLC, dba Thrive Health Solutions |
03 Apr 2025 | Normal | Justification: The cleanliness of surfaces directly impacts the primary packaging step, where unclean surfaces can contaminate products. Excerpt: The work surface is not disinfected prior to packaging vials into syringes. View Details |
| Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed Somerset Therapeutics Private Limited |
21 Feb 2025 | Normal | Justification: Observation indicates primary packaging components contact non-sterile surfaces, compromising sterility. Excerpt: The Grade A equipment surfaces that come in contact with the sterile primary packaging components are not always sterile. View Details |
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