GMP for MIA HOLDERS

Program

Introduction to GMP

• Production legislation for pharmaceuticals

• European GMP guidelines and connections

• Goal and importance of GMP

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Base Principles

• Personnel and outsourcing

• Facilities and equipment

• Production, documentation, validation

• Quality control and self-inspection

• Complaints and recall

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GMP Quality System

• Quality concepts

• Install and maintenance of quality systems

• Applying quality systems

• GMP quality system components

• GMP quality system in effect

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Export and/or Import Activities

• Which GMP aspects are concerned?

• What is applicable to MIA holders?

• How to comply with GMP requirements for MIA holder?

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Batch Certification by MIA Holders

• Annex 16

• QP activities and oversight for export-import activities

• Work organization

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