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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 |
|---|---|---|---|
| Written procedures are not followed for the receipt, storage and handling. Bausch and Lomb Incorporated |
20 Mar 2026 | Normal | Justification: The observation details failures in documenting arrivals and incorrect placement in storage, directly impacting material handling processes. Excerpt: Failed to document and complete the Purchasing Notification of Missing Documents Form (SOP21-076 Form B). View Details |
| Failure to reject any lot of drug product containers that did not meet the appropriate written specifications Eosera, Inc. |
20 Mar 2026 | Normal | Justification: Defective containers at receipt were not flagged or rejected, implicating the material handling process. Excerpt: Failed to reject lot #(b) (4) of (b) (4) bottles after finding imperfections. View Details |
| Control procedures fail to include adequate steps to ensure that manufacturers know the identity of each batch of material Grifols Diagnostic Solutions |
13 Mar 2026 | Normal | Justification: The control procedures did not verify the identity of batches, affecting Material Receipt and Handling. Excerpt: A) The Quality Unit did not adequately ensure that the identity of each batch of incoming active pharmaceutical ingredients was determined before use in the manufacturing process. View Details |
| You did not establish written procedures describing the identification of components Isorx Cyclotron Center |
13 Mar 2026 | Normal | Justification: Material receipt and handling directly affect identification and traceability of components, critical for compliance. Excerpt: Your SOP does not address receiving the same product with the same lot number on a different day. View Details |
| The quality control unit lacks the responsibility and authority to approve and reject all components. COSMETIC LABORATORY INC |
10 Mar 2026 | Normal | Justification: Subpotent raw materials were accepted and used possibly due to ineffective handling and testing protocols. Excerpt: Your firm uses subpotent raw materials in the manufacture of your firm's OTC drug products. View Details |
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