003 OPM r12 Quality v1.0 | Specification (Technical Standard) | Supply Chain

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Quality for Oracle Process Manufacturing
AGSS Process Manufacturing Sales Support Team

Agenda
‡ General concepts ‡ Process Quality Solution
‡ Key Functionality

‡ Additional resources

<Insert Picture Here> General Concepts .

Manufacturing Building Blocks Analysis Costing Product Development Planning Purchase Produce Order Management Quality Inventory .

Quality Management Analysis Costing Product Development Planning Purchase Produce Order Management Quality Inventory .

In Process.Process Manufacturing Quality Flow Quality Characteristics of Material ‡ Receiving. Shipping Inspection ‡ Lot Expiration/Retest ‡ Environmental Monitoring ‡ Material Usage Decisions ‡ Batch Adjustments ‡ Order Allocation Standardize Sample Analyze Disposition Report ‡ Tests and Methods ‡ Sampling Plans ‡ Specifications ‡ Result Statistics ‡ Stability Studies ‡ Certificate of Analysis ‡ Lot Genealogy Process Improvement WorkflowWorkflow-Driven Processes and Electronic Records .

<Insert Picture Here> Process Quality Solution .

Process Quality Solution Enables you to: ‡ ‡ ‡ ‡ Achieve product consistency Enforce proactive quality assurance Streamline quality lab productivity Assure customer and regulatory compliance .

Key Functionality ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ Standardized inspection methodologies Stability studies Workflow driven quality management Customer specification matching at order Parent / Child lot traceability Certificate of Conformance and Analysis Quality driven lot usage decisions Expired lot management .

Standardized Inspection Methodology Quality Setup Specification / Validity Rule Approval WF WF Sample Creation Notification Workflow WIP Sampling Information Composite Results Specifications Definition ERES ERES Samples WF Creation Testing Notification Workflow WF ERES Results Entry & Evaluation Item/Lot UOM WF Conversion WF Sample/Sample Group Disposition Approval. Sample Group Rejection ERES .

Stability Studies Determine Product Shelf Life and Market Conditions ‡ Stability study management: ‡ ‡ ‡ ‡ Assess environmental aging effects on product quality Capture recommended shelf life and storage condition Support research and development activities Comply with FDA guidelines in regulated industries ‡ Implementation methodology via workflow and project-oriented interface Stability Samples Batches 0 months 40°C 75% relative humidity 3 months 40°C 75% relative humidity 6 months 40°C 75% relative humidity .

Stability Studies Measure the Effects of Environmental Aging Base Monitoring Specification 0 1 3 6 9 12 18 24 months 0 1 23 Production Batch Stability Samples 0 6 months Overlay Monitoring Specification (1) Study Definition ‡ Sample Numbering ‡ Monitoring Specs ‡ Storage Conditions ‡ Storage Packaging ‡ Testing Intervals ‡ Item Specs 12 months Overlay Monitoring Specification (n) Work Flow Notices Lab Study Lab Study Execution Technician Owner Supervisor ‡ Ensure Timely Execution of All Data Points ‡ Assess Product Quality Over Time and Varying Environment ‡ Capture Recommended Shelf Life and Storage Condition ‡ Support Research and Development Activities ‡ Comply With FDA Guidelines in Regulated Industries .

Pre-Defined Quality Workflows Check Quality Throughout the Supply Chain Receiving  Inventory  Shipping Suppliers  Production  Customers Automatic Workflow Notifications at Each Quality Check Point for:  Quality check points ‡ Sample Creation ‡ Assay Testing ‡ Sample Disposition Decision .

Specifications Management Unique Customer Specifications Customer Specification Item Specification Min Out-of-Spec In-Spec Out-of-Spec Match Max ‡ Define internal and customer products specifications ‡ Match available inventory to customer specifications ‡ Provide Certificate of Analysis (COA) with each shipment .

Global Traceability Reduce Time to Resolve Issues Lot Source Supplier Ingredients & Resources Intermediate or Bulk Products Finished Product Customers Where Used ‡ Improve recall responsiveness / cost ‡ Comply with FDA. GMP. and other regulations ‡ Trace materials enterprise-wide to analyze supply chain quality .

Certificate of Conformance or Analysis Assure Product Quality Through Documentation ‡ Certify material for conformance to manufacturer¶s or customer¶s specification ‡ Print specification requirements and/or results ‡ Run separately or attach to shipment document set .

Quality-Driven Lot Usage Decisions Manage Ingredient Variability for Consistent Products INVENTORY QUALITY AVAILABILITY ‡ ‡ ‡ ‡ Shelf life Retest interval Potency Dual units of measure (UOM) ‡ Sample lots ‡ Evaluate for conformance to specification ‡ Accept or reject ‡ ‡ ‡ ‡ ‡ Expiration date Lot status Grade Hold date Lot UOM conversions .

Expired Lot Management Validate and Manage Date-Sensitive Goods ‡ Notify when lots expire or require retesting ‡ Change expired lot status to prevent usage ‡ Manage retesting ‡ Lot retest sample ‡ Lot retest tests from the specification .

quality throughout the supply chain ‡ Enforce proactive quality assurance ‡ Standardized inspection methodology. quality workbench ‡ Assure customer and regulatory compliance ‡ Customer spec matching. lot traceability . process control points. CofA / CofC. e-records and e-signature ‡ Streamline quality lab productivity ‡ Automated test/lab assignment.Process Quality Solution Enables you to: ‡ Achieve product consistency ‡ Stability studies. workflow. lot expiration management.

<Insert Picture Here> Additional Resources .

com Mobile 201-218-3245 Office 201-794-6221 .com Mobile 502-xxx-xxxx ‡ David Ballin ± AGSS ± SCM Solution Architect David.hyers@oracle.com Mobile 972-xxx-xxxx ‡ Andrew Hyers ± AGSS ± SCM Solution Specialist Andrew.ballin@oracle.Additional Resources ‡ Vivian Lewis ± AGSS ± SCM Solution Specialist Vivian.Lewis@oracle.

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