# 248 - What Is a Quality Unit? QA vs. QC Explained

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Text version: https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248/248-what-is-a-quality-unit-qa-vs-qc-explained.md
Podcast: [Let's Combinate - Drugs + Devices](https://stenobird.com/podcast/let-s-combinate-drugs-devices-4474248)
Published: 2026-07-29T10:00:00+00:00
Episode link: https://podcasters.spotify.com/pod/show/letscombinate/episodes/248---What-Is-a-Quality-Unit--QA-vs--QC-Explained-e3mm6oe
Audio file: https://anchor.fm/s/6770b9a0/podcast/play/123459790/https%3A%2F%2Fd3ctxlq1ktw2nl.cloudfront.net%2Fstaging%2F2026-6-29%2F428804538-44100-2-6e99e5575d3cd.mp3
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Duration seconds: 534

## Resource

What is a Quality Unit and how do Quality Assurance and Quality Control fit within it? In this episode, I explain the practical differences between the Quality Unit, QA, and QC across pharmaceutical, medical-device, and combination-product companies. We’ll look at the Quality Unit’s major responsibilities, why QA is generally system- and process-focused, why QC is generally testing- and product-focused, and why the organizational structure varies between companies. CHAPTERS 00:00 What is a Quality Unit? 01:18 The Quality Unit as the umbrella function 01:55 Three major Quality Unit responsibilities 03:08 What functions may sit within Quality 04:08 Establishing, operating, and releasing 04:37 Quality Assurance vs. Quality Control 05:38 Common QA responsibilities 06:16 Common QC responsibilities 06:53 Why pharma and device companies look different 07:32 Drug vs. device terminology 08:06 How QC supports product release 08:26 Final QA vs. QC summary KEY TAKEAWAYS • The Quality Unit provides overall quality oversight. • QA primarily focuses on systems and processes. • QC primarily focuses on inspection, measurement, and testing. • QC testing provides essential evidence supporting product disposition. • Exact responsibilities and reporting structures vary by company and industry. How are QA and QC organized at your company? Share your experience in the comments. #QualityAssurance #QualityControl #QualityUnit #Pharma #MedicalDevices #qualitymanagement Subhi Saadeh is a quality professional, consultant, auditor, and trainer who specializes in drug-device combination products, medical devices, pharmaceutical quality systems, supplier quality, and lifecycle management. Through Let’s Combinate, he helps pharmaceutical and medical device teams bridge the gap between drug and device…

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## Transcript

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