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Posted on April 15, 2025April 14, 2025
The Hidden Risks of Ignoring Sterility Discrepancies

In our latest GMP Trends Report Issue #1158, a particularly concerning observation was noted regarding […]

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Posted on April 1, 2025April 2, 2025
Data Integrity: A Consistent Challenge in GMP Compliance

Our latest GMP Trends Report Issue #1157 highlights troubling patterns that underscore the ongoing need […]

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computer system validation
Posted on March 14, 2025March 13, 2025
Are your internal auditors independent?

A notable FDA 483 observation from our recent GMP Trends Issue 1156 has revealed multiple […]

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cleaning validation
Posted on February 28, 2025February 27, 2025
The Importance of Batch Traceability

A recent FDA 483 observation highlighted in GMP Trends Issue 1155 notes a critical lapse […]

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Employee training for pharmaceutical GMP
Posted on February 14, 2025February 18, 2025
Change Control Gaps Exposed: What recent FDA Inspections Are Revealing

If FDA is inspecting your firm, one of the first places they will investigate is […]

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gowning - gmp
Posted on January 31, 2025January 30, 2025
Are you adequately controlling your rejected materials?

In our February 1st Issue, we highlight a specific 483-observation concerning rejected secondary packaging materials […]

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Annual Product Reviews can be a “Team Sport”  
Posted on January 15, 2025January 28, 2025
Annual Product Reviews can be a “Team Sport”  

In GMP Trends Issue Number 1152, we highlight observations related to manpower limitations and the […]

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Are Your GMP Systems Overly Reliant on Your Supplier’s Certificates of Analysis?
Posted on January 1, 2025December 31, 2024
Are Your GMP Systems Overly Reliant on Your Supplier’s Certificates of Analysis?

As noted in our January 1st, 2025 report –  some companies are overly reliant on […]

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Does your validation protocol include requirements for stability testing?
Posted on December 16, 2024December 16, 2024
Does your validation protocol include requirements for stability testing?

In GMP Trends Issue #1150, a noteworthy observation was reported regarding a bulk API manufacturer […]

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Posted on December 2, 2024December 1, 2024
Is your internal audit program robust enough to cover your next FDA inspection? 

In a recent FDA inspection, a medical device manufacturer was cited for failure to conduct […]

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GMP TRENDS is a publication for the pharmaceutical and medical device industries, trending observations made by FDA investigators during GMP inspections throughout the world.

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