Responsible Person (RP) Roles and Responsibilities SOP
GDP RP responsibilities.
2 800 Skr
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Purpose:
This SOP defines the roles, responsibilities, authority, and oversight duties of the Responsible Person (RP) in relation to wholesale distribution activities conducted under EU GDP requirements.
Regulatory Alignment:
EU Guidelines on Good Distribution Practice (2013/C 343/01) and Wholesale Distribution Authorisation (WDA) expectations.
Included Files:
• SOP – Responsible Person (RP) Roles and Responsibilities
• RP responsibility matrix
• RP oversight and review checklist
Format:
Microsoft Word (fully editable)
Intended Users:
Wholesale distributors, marketing authorisation holders, Responsible Persons, and quality assurance teams involved in GDP-regulated activities.