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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 |
|---|---|---|---|
| Deviations from written production and process control procedures are not recorded and justified. Alkem Laboratories Limited |
01 May 2026 | Normal | Justification: The observation highlights unrecorded and unjustified deviations, pointing to flaws in deviation management processes. Excerpt: Deviations from written production and process control procedures are not recorded and justified. View Details |
| Your examination and testing of samples did not assure that the drug product and in-process material conformed to specifications. Alkem Laboratories Limited |
01 May 2026 | Normal | Justification: Deviation handling failures indicate a breakdown in the systems capturing alterations from standard conditions. Excerpt: No manufacturing deviations or documentation in the executed batch records were available for these failures. View Details |
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Charles River Laboratories, Inc. |
27 Mar 2026 | Normal | Justification: Correct classification ensures proper risk management. Excerpt: Deviation DEV-03248 was classified as minor, despite potential impact... View Details |
| Your firm lacks adequate quality unit investigations for deviations to implement corrective actions to prevent recurrence. Hospira, Inc. |
10 Mar 2026 | Normal | Justification: The observation points to repeated deviations due to ineffective investigations, directly impacting deviation management process. Excerpt: Your firm lacks adequate quality unit investigations for deviations to implement corrective actions to prevent recurrence. View Details |
| Your firm failed to conduct an annual product quality review of your API. Aurorium LLC |
06 Mar 2026 | Normal | Justification: The deviation report for the annual review was initiated but lacked critical details necessary for compliance. Excerpt: The deviation is still open. View Details |
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