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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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Does the President of Your Company Know Their Job Responsibilities?
Posted on November 15, 2024November 13, 2024
Does the President of Your Company Know Their Job Responsibilities?

The latest observations from GMP Trends Report #1148 revealed a series of significant compliance gaps […]

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Posted on November 1, 2024October 28, 2024
The Changing Landscape of Complaint Handling

Written complaints have historically been prioritized and more scrutinized by industry, viewing them as more […]

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Posted on October 15, 2024October 12, 2024
Is your stability study program properly designed to assess the stability of product in the field?

A recent inspection revealed a concerning discrepancy between retain samples and the actual marketed products, […]

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handling rejected products
Posted on October 1, 2024September 30, 2024
Do your customer invoices include lot numbers and expiration dates?

In a recent 483, a relabeler was cited for failing to have lot numbers and […]

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Posted on September 16, 2024September 13, 2024
Have you integrated your CAPA and Customer Complaint Programs? 

A medical device firm recently received a 483 from FDA for failing to integrate their […]

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