6 WAYS to Getting the Supply Chain in Sync

GLOBAL COMPLEXITY

INTEGRITY REQUIREMENTSGUIDELINES

RESOURCES FRAGMENTATION IMPLEMENTATION OF CHANGES

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Multi-sites:

• Manufacturing

• Distribution

• Testing

• Allow Flexible Multi-site Activities

• Counterfeit

• Theft

• Anti-Counterfeit

• Secure Supply Chain

Capacity Issues:

• Backlog

• Reviews

• Inspections

• Training to Strengthen Expertise

Mutual Recognition:

• Reviews

• Inspections

• WHO Training and Workshops

Divergent:

• Submission Categories

• Review Times

• Standard Submission Categories

• Standard De�ned Review Times

Divergent:

• Guidelines

• Data Requirement

Convergent:

• Guidelines

• Data Requirement

Mandatory:

• Minimum Inventory

• Product Speci�c Monograph (PSM) Adherence

• Release Testing

• Inventory to Meet Needs

• PSM not Applicable for Biotech Products

• Reduce Redundant Release Testing

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