What is Quality System Regulation (QSR)?

Quality System Regulation Definition

The FDA’s quality system regulation (QSR) as defined in 21 CFR Part 820 states that manufacturers should establish and follow a quality system to help ensure that their products consistently meet applicable requirements and specifications. Quality systems for FDA-regulated products are known as current good manufacturing practices (CGMPs).

FAQs

What is QSR in manufacturing?

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What does QSR stand for in medical devices?

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What is a QSR FDA?

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What does QSR apply to?

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