EU GMP

EU GMP Chapter 1 & Chapter 2 - Quality Management and Personnel

The pharmaceutical quality system principles in Chapter 1, and personnel organization and qualification requirements in Chapter 2.

What this course covers

This course covers the pharmaceutical quality system principles set out in EU GMP Chapter 1 and how they compare to ICH Q10, alongside the personnel organization, responsibility and qualification requirements in Chapter 2. It highlights where EU GMP's personnel expectations diverge from FDA's 21 CFR Part 211 approach.

Who this course is for

QA management at EU-regulated or EU-supplying sites
Personnel and training coordinators building qualification records
Anyone working across both FDA and EU GMP frameworks

What you'll learn

The pharmaceutical quality system principles set out in EU GMP Chapter 1
How EU GMP's PQS expectations compare to ICH Q10
Personnel organization and responsibility requirements under Chapter 2
Qualification and training expectations for key personnel
Where EU GMP Chapters 1 and 2 diverge from FDA's Part 211 personnel requirements

Why it matters

Sites that supply both US and EU markets often build a single quality system to satisfy both frameworks. Understanding exactly where EU GMP and FDA expectations align and where they diverge prevents building redundant, conflicting, or gap-ridden procedures.

Included in the full GMPify subscription

Completion certificate, PDF slide download, and access to the complete GMP course library from day one.

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