Is Your cGMP Quality System Ready For An FDA Inspection?

Is Your cGMP Quality System Ready For An FDA Inspection?

March 30th, 2022 // 5:54 pm @

At this year’s PDA/FDA conference, FDA’s Director for the Division of International Drug Quality Carmelo Rosa offered the agency’s regulatory point of view on pharmaceutical quality systems. She also detailed some of the latest FDA audit trends of drug facilities.

Rosa noted as she reviewed the most frequent FDA warning letter observations for drug manufacturers from 2018 to 2020, the #1 citation revolved around process control, process validation, and investigating discrepancies.

Another major warning letter item for drug manufacturers during this timeframe was not testing components for identity. Other common warning letter citations were failing to test finished product and inadequate stability tests.

Similar observations can be found when looking for common cGMP violations that were given to API manufacturers from 2018 to 2020.

Rosa said failing to investigate OOS results was one of the top observations.

All of these citations have one thing in common – a quality system that needs improvement.

Robust Quality System Needs Strong FDA Compliance

How does the FDA auditor determine that your company has a strong quality system? Rosa explained at the PDA conference that when companies give their response to an FDA 483 or warning letter, they address the issue but don’t focus on an overall reassessment of the quality system.

FDA wants to see in the response the evidence that the companies are using tools to ensure quality and are using correct quality risk management methods.

As an example, Rosa pointed out batch failure investigations, which is one of the most common 483 and warning letter citations since 1990. She noted that FDA continues to see this problem, so it makes them conclude there is something amiss in the quality system that cannot ID the root cause.

He added that FDA often criticizes test methods in the warning letter, and when they get the company response, it validated the test method. But when the FDAer returns to the plant, they find that other test methods weren’t checked.

Other major concern areas for FDA about quality systems include supplier qualification, quality management, and adequacy of the change control program.

Companies Must Connect The Dots

Carmelo said that FDA connects the dots during inspections and companies need to do it, too. For example, during an inspection, the FDAer will review complaints and see how they are connected to investigations, and then they notice impurities.

Next, FDA connects these trends to cleaning methods, to complaints again, and to any situation or incident that suggests there could be a bigger problem the company is missing. The overall problem here is being reactive instead of preventative.

The FDA regulator also said that a drug company’s pharmaceutical system must operate in full compliance with cGMPs and stay in a controlled, sustained state. This state requires company leaders to have a commitment to quality, enough resources, and a QRM approach.

This is a dynamic state that must involve total product and process understanding. These attributes are vital to transition from a reactive to proactive state and to reach a state of continual improvement.

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