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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 |
---|---|---|---|
(b) (4) are not checked for accuracy. ARUP Laboratories, Inc. |
06 Nov 2024 | Normal | Justification: Issues arose from poor lifecycle management practices, failing to incorporate adequate testing and validation phases. Excerpt: Your firm failed to adequately test the (b) (4) of your new (b) (4) related to your (b) (4). View Details |
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Nephron Sterile Compounding Center LLC |
10 Feb 2023 | Normal | Justification: Software Lifecycle Management is necessary to ensure any software used in the manufacturing processes is validated and maintained over time, preventing potential compliance issues. Excerpt: Ensure software validations and process validations are performed. View Details |
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