1. Lesson 7: BRITE Seminar: GMP II
Jenae Williams - Learning Consultant

2. Supply Chain Function and Roles
After today you should be able to:
Explain the Function of Supply Chain
Discuss the impact of non compliance in various areas within a cGMP environment

3. Manufacturing Function and Roles
Support Roles:
Quality Assurance Function and Roles
Corporate Quality Assurance Function and Roles
Quality Control Function and Roles
FUME Function and Roles
Supply Chain Function and Roles
Technology Development Function and Roles
Regulatory Function and Roles
Research and Development Function and Roles
Medical and Clinical Research Function and Roles

4. Supply Chain Functional Components
Product Security
Product Storage and Distribution
All Components of Supply Chain
Contract Manufacturing Organization (CMO) Management
Shipping Qualification
NEXT

5. Supply Chain
This functional area manages all aspects of the flow of materials and product into and out of a company which may include
Handling of Raw Materials
Label and Packaging Materials
Components and Products
Management of Suppliers and Contract Manufacturing Organizations

6. Product Security
Product security personnel ensure that all processes, procedures and quality agreements are in place for the security of all products from distribution sites
Personnel are responsible for ensuring product is not stolen, tampered with or counterfeited (product authenticity and identification is verified)
Products are labeled with required identifiers
Suspect/illegitimate/Falsified products are handled and reported
Product theft and safety are managed according to procedure

7. Product Storage and Distribution
Product storage areas must be sufficiently controlled
to prevent mix ups
Damage
Deterioration
Contamination
Adverse effects to product
Stock should be stored at appropriate storage conditions
Finished goods must be held in Quarantine until release
First expires stock of finished goods must be distributed first
Products must be transported in a manner that does not adversely impact quality
Documentation of transport conditions is required
A system is maintained to track distributed products
Counterfeited or tampered products must be identified, segregated and quarantined

8. Shipping Qualification
Qualified Shipping systems will be applied to ensure commercial product integrity
Systems and processes are continuously monitored to ensure operation in a qualified manner

9. CMO Management
Assess that the CMO shows the following for appropriate intended use:
Competence
Capacity
Resources
CMO requires that all product related information is appropriately communicated
Prevents product adverse events
Prevents injury to CMO personnel
Ensure that work is not transferred to a third Party
All production processes must be documented
All changed must go through the appropriate change control process

10. Supply Chain Role Examples
Supply Chain Associates
Project Manager
Most Management and Executive Levels

12. Next Week: Technology Development Function and Roles
Debrief
Attendance