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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 |
|---|---|---|---|
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed Aurobindo Pharma Limited, Unit VII |
10 Feb 2026 | Normal | Justification: Sample Management is directly impacted due to improper collection and handling, leading to false data entries. Excerpt: Microbiologists potentially falsified sample collection data and skipped primary gowning. View Details |
| Established sampling plan and test procedures are not followed Global Calcium Pvt. Limited |
03 Feb 2026 | Normal | Justification: Sample management is linked as deficiencies were observed in documented sampling activities versus biometric access logs. Excerpt: Water Sampling Register does not match biometric access logs, indicating procedural breakdown in sample management. View Details |
| Established sampling plan and test procedures are not followed Gland Chemicals Private Limited |
27 Nov 2025 | Normal | Justification: Sample Management is impacted as discrepancies in presence documentation risk sample integrity and trustworthiness of data. Excerpt: The biometric access control system does not show that employee entered the room during the sampling period. View Details |
| The responsibilities and procedures applicable to the quality control unit are not fully followed. Lupin Limited |
21 Nov 2025 | Normal | Justification: Sample management issues are evident from missing reconciliation and unrecorded test details. Excerpt: Quality unit has not reconciled all the received and tested samples with corresponding test results and reports. View Details |
| Established sampling plans and test procedures are not followed and documented at the time of performance Pharmathen International S.A. |
21 Nov 2025 | Normal | Justification: Sample management involves tracking and documenting sampling activities as substantiated by observation in environmental sampling records. Excerpt: Analysts were observed filling out the sampling information onto the paperwork during plate reading... View Details |
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