Redica Responds is an article series where we take common/unique questions from customers and industry events and answer them with our data. Use the following link to look at all previous Redica Responds articles.

My site has a quality system in place. Can I just leave it alone?

FDA and other regulatory inspectors expect to see that manufacturers have implemented a robust quality system

So, when it comes to your quality system or quality unit, is merely having one in place enough to satisfy inspectors?

What does Redica Systems data say? 

For the period of 2017-2021, there were 63 primary 483 observation issues involving missing quality units. The total observations for quality unit issues as a whole, including lack of a quality unit, were 459. 

So, missing quality units accounted for almost 14% of the total quality unit-related observations.

(Keep in mind this was for sites in North America.)

Quality Unit Primary 483 Observations
Redica Systems | Quality Unit 483 Observations (Primary)

For secondary issues, the percentage of missing quality unit observations was higher at 26% The number of secondary issues involving missing quality units was 38 out of 142 quality unit issues total.

While there are sites in North America that lack a dedicated quality unit, other issues involving the quality unit are more prevalent. These generally point to systemic issues involving quality culture

What does this mean for your site’s quality system? Just because you have a quality unit, it does not mean you can implement it and call it a day. Remember, quality should be supported top-down within an organization.

Stay on Top of Quality Trends with Redica Systems

We recognize that quality and compliance teams at firms of all sizes need to stay on top of the latest inspection trends affecting the quality unit.  Redica Systems is a quality and regulatory data analytics platform that helps the life sciences industry improve quality and stay on top of evolving regulations.

Contact us today to see how our actionable intelligence can help your team stay on top of quality.

Additional Resources

Is Your Quality System Up to Par for Your Next FDA Inspection?

Can Quality Culture Prevent GMP Issues Such as Data Integrity?

Quality Culture Assessments and Records Request Responses

Top 10 Responsibilities of the Pharma Quality Unit

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