What are the number of FDA 483 observations involving change control procedures over the past ten years?

Effective change control procedures are one area of concern for FDA investigators. It is important for manufacturers to be aware of how changes might impact finished product. 

Redica’s Barb 2.0 Report (named in honor of GMP Consultant Barbara W. Unger) can show us the number of FDA 483 observations involving change control from over the past ten years for human drug GMP operations across the globe. In Redica, change control falls under the “Quality Unit” category.

The resulting report shows 1,577 observations over the past ten years for change control.

Change Control 483 observations
Redica Systems Enforcement Analytics | Change Control 483 Observations

Change Management Inspection Case Study

At the March 2022 International GMP Conference FDA investigator Ileana Barreto-Pettit presented a case study involving lack of an adequate change management process at a manufacturer. In this case, an API manufacturer was cited for failing to evaluate the potential impact of changes on intermediates and API.  

The manufacturer conducted a small-scale experiment to see if the specification of the starting material could be increased. Doing so could potentially cause new impurities to form in the product, so a new purification step was added. Investigators, however, noted that the firm relied on laboratory-scale batches instead of full-scale validation batches. Personnel also failed to test validation batches of the API for new impurities as they continued to rely on the older analytical method.

How Redica Can Help You with Change Control

With Redica, human drug manufacturers can leverage our deeper intelligence about inspection trends and investigator tendencies for thorough inspection preparation.

Strategic inspection preparation based on current inspection findings at your sites and others. Find trends in the data to identify where to focus your attention.

Tactical inspection preparation using complete FDA investigator profiles. What do they tend to look for? What do they tend to find?

Contact us today to learn more about how Redica can help you stay on top of your strategic and tactical inspection preparation.

Additional Resources

Change Management Failures Documented in FDA Warning Letter

Report – 4 GMP Case Studies Including FDA Findings and Concerns