as of 2019 - 05 - 07

14.I Batch Release

14.I Batch Release
Here you will find answers to the following questions:

What does a EU-compliant batch release of medicinal products look like and what individual steps does it involve?

What requirements does it have to meet?

What requirements apply to imported products?

What responsibilities does the certifying Qualified Person have and how can he/she fulfil them?

What support systems are available to the Qualified Person?

What responsibilities does the certifying Qualified Person have for products fully or partially manufactured by contract manufacturers?

How can the certifying QP meet the challenges of a complex global product/process flow?

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