Presentation title 20/Apr/07

Reporting
Transport
Problems
Ed. 3.0
ROFE Quailtiy
MRA
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Reporting Transportation Problems Ed.3.0

• Purpose
• Revision performed on Doc. No. 103754 to comply with
the current edition of Doc 040747 and NN SOP Template.
• Scope
• Now covers all affiliates in Region Far East

• Updates
• Cox Recorder was replaced by Temperature Monitoring
Device
• QAIC replaced by QALMD
• Transport problems replaced by Transport Deviations
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Reporting Transportation Problems Ed.3.0

• Included in the document:

• Figure 1 Flow of products from Novo Nordisk

Production Sites to the End-UserSection
• Abbreviations and Definitions
• Section – Responsibility
• Transportation of products for clinical trials is
not covered by this procedure
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Reporting Transportation Problems Ed.3.0

What to do?
• LQRP reports Temperature Deviations to
• QALDM using Temperature Deviation Report from Doc.
No. 040747 (Ref.1.0)

• Local CS reports Transport Deviations to:

• TPRS using procedure Doc. No. 103754 (Ref. 2)