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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 |
---|---|---|---|
Established sampling plans are not documented at the time of performance. Central Admixture Pharmacy Services Inc |
25 Aug 2023 | Normal | Justification: Line clearance processes require detailed and real-time documentation of activities to ensure complete traceability and accountability. Excerpt: The firm only documents the time the batch starts VI and at the end of labeling in the Line Clearance logbook. View Details |
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Takeda Pharmaceutical Company Limited |
26 Nov 2019 | Normal | Justification: Improper line clearance indicates a lapse in ensuring clean and segregated manufacturing operations. Excerpt: Ensure are reconciliated and 100% line clearance, accountability, segregation, and (b) (4) destruction are performed. View Details |