industry perspectives veterinary drug supply …...sep 26, 2019 · issue drug product supply...
TRANSCRIPT
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INDUSTRY PERSPECTIVESVETERINARY DRUG SUPPLY INTERRUPTIONS
Jeanne Greenwald
Director Regulatory Affairs
September 26, 2019
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Supply Chain
Technical
Quality
Procurement
Regulatory
Production
• Identify and solve the technical issues
• Provide options
• Auditing/Correction• Investigation/Correction• Test and Release• Recalls/Field Alerts
• Manufacture batches
• Work closely with technical groups
• Regulatory strategy• Regulatory submissions• Communicate with
authorities• Manage supplier
relationships• Source new suppliers
Prevention/Mitigation of Supply Disruptions
Other functions, as needed
• Determine supply/demand
• Allocate, if needed
Core Team
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Example 1
Issue API Production Interruption
Root Cause Industrial Hygiene Issue
Impact Disruption of Product Supply for Several Weeks Anticipated Once API
Stock is Consumed
Mitigation Work with Supplier to Minimize Disruption
Prevention Qualify Alternate API Supplier
-technically challenging
-will take over a year, which will not mitigate this disruption, but could
prevent in future
Anticipate Industrial Hygiene Issues at Suppliers?
Larger Safety Stock of API?
Involved Functions Technical, EHS, Supply Chain, Procurement, Production, Quality,
Regulatory
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Example 2
Issue API Intermediate Supplier Stops Manufacture
Root Cause Raw Material Used to Manufacture Intermediate Changed and Supplier Cannot Meet Required Quality for Intermediate
Impact Potential for Disruption of Drug Product Supply
Mitigation Work with Intermediate Supplier to Bridge the Gap
Use Existing Alternate API Supplier (Can they supply enough? Registered in all markets?)
Prevention Qualify a new supplier of the intermediate
Involved Functions
Technical, Supply Chain, Procurement, Production, Quality, Regulatory
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Example 3
Issue Contract Manufacturing Organization (CMO) Stops Manufacture of Drug Product
Root Cause FDA Inspection Deficiencies Caused CMO to decide its not worth remediation
Impact Disruption of Drug Product Supply in the US once Stocks are ConsumedMedically Necessary Veterinary Product?
Mitigation Temporary import of EU product?Compounding?Regulatory Supplement to Introduce EU Manufacturing Site (expedited CVM review?)
Prevention Alternate Drug Product Manufacturing SiteBetter Anticipate CMO Quality DeficienciesGenerics? New Products?
Involved Functions
Technical, Supply Chain, Procurement, Production, Quality, Regulatory
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Objective – Alternate AExample 4
Issue Drug Product Supply Interruption,
Product Fails to Meet a Specification on Stability
Root Cause Site Transfer of Product
Critical Manufacturing Process Step Not Well Enough Defined
Impact Long Term Disruption of Product Supply in the US while the issue was
investigated and solved
No disruption in other markets
Mitigation Switch US Customers to Alternatives
Allocate Compliant Product to US Customers that Cannot Easily Switch
Prevention Establish Critical Process Parameters
New Products, Generics
Involved Functions Technical, Supply Chain, Procurement, Production, Quality,
Regulatory, R&D
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My Conclusions:
• There is a constant threat of supply disruptions for veterinary drugs
• The types of threats vary
• We must be proactive to head off the threats
• When a disruption cannot be avoided, then we must mitigate, where possible, to minimize the interruption
• All core functions need to be engaged in order to be successful
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THANK YOU!
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