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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 |
|---|---|---|---|
| Failure to maintain equipment used in the storage and distribution of blood and blood products Methodist Hospital Blood Bank |
18 Mar 2026 | Normal | Justification: Cold Chain Management critical as improper freezing impacts blood product integrity and safety. Excerpt: The (b) (4) Freezer malfunctioned and the monitoring temperature dropped below the acceptable range. View Details |
| You did not take corrective action that ensured affected product was not entered into commerce JFC International, Inc |
20 Feb 2026 | Normal | Justification: The reliance on temperature control during transport directly aligns with cold chain management failures. Excerpt: Temperatures exceeding established critical limits during transport, yet products were accepted without adequate corrective actions. View Details |
| There is a failure to handle and store components, key starting materials, API containers, and closures at all times Piramal Pharma Limited |
17 Feb 2025 | Normal | Justification: Cold chain management ensures that temperature-sensitive materials maintain their required storage conditions from receipt to usage, preventing degradation. Excerpt: Key Starting Materials (KSMs) labeled with frozen and refrigerated storage requirements are shipped and received at the firm via room temperature conditions. View Details |
| SOP for critical steps in shipping is inadequate Boehringer Ingelheim RCV GmbH & Co KG |
05 Dec 2023 | Normal | Justification: Cold chain management is essential for preserving product quality during shipping, thus SOP must include detailed instructions. Excerpt: does not describe the duration in which the drug substance final containers need to be loaded... View Details |
| SOP for critical steps in shipping is inadequate Boehringer Ingelheim RCV GmbH & Co KG |
05 Dec 2023 | Normal | Justification: Cold chain management is essential for preserving product quality during shipping, thus SOP must include detailed instructions. Excerpt: does not describe the duration in which the drug substance final containers need to be loaded... View Details |
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