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

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

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

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

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

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

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

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

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

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

Next Week: Technology Development Function and Roles Debrief Attendance