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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 |
|---|---|---|---|
| Your firm failed to exercise appropriate controls to protect the electronic data acquisition and process control systems Alvotech HF |
04 Jul 2025 | Normal | Justification: Access controls are crucial for ensuring accountability and preventing unauthorized system changes. Excerpt: Your staff used a shared username and password to log into a lantopi. View Details |
| Your firm's documentation practices are deficient. Alvotech HF |
04 Jul 2025 | Normal | Justification: User Access and Controls are essential to maintaining security and confidentiality of GMP documentation. Excerpt: Your firm failed to implement appropriate access control over GMP records. View Details |
| Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data Concord Biotech Limited |
02 May 2025 | Normal | Justification: The lack of individual user credentials is indicative of a significant gap in the 'User Access and Controls' process. Excerpt: Analyst can login with common username "operator"; your Quality Assurance department uses a common username "CBL\qa". View Details |
| (b) (4) are not checked for accuracy. ARUP Laboratories, Inc. |
06 Nov 2024 | Normal | Justification: The observation focuses on failure to restrict access permissions, a critical aspect of User Access and Controls. Excerpt: Your firm was unaware that the employee had the permissions to (b) (4) a donation (DEV-2024-0262). View Details |
| Standard operating procedures (SOP) supporting manufacture of drug product are deficient or are not followed Baxter Oncology GmbH |
27 Aug 2024 | Normal | Justification: Access control failures could lead to unqualified personnel entering critical GMP areas, risking compliance. Excerpt: "Access control system failing to track when a revocation of access rights is performed" View Details |
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