Responsible Person for GDP: Refresher

Program

Management of Authorized Activities

• Which activities (purchase, storage, supply, export)

• Type of products (cold chain, psychotropics, ...)

• Supply chain of products (physical + financial flow): from manufacturer to customer

• Samples

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Quality Management System

• Activities, processes, responsibilities

• Structure

• GDP risk assessment

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Complaint Handling

• Quality vs distribution

• RP oversight

• Timelines + link with recall and PV

• Interaction with supplier, warehouse, transporter

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Returns

• Risk based approach

• Visual check

• Document check

• Declaration storage conditions

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