Monitoring The Cold Chain: Proving You Kept Things Cold
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Monitoring The Cold Chain Nick Kovacic
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Nick Kovacic walks you through how to prove you kept your products cold in the Cold Chain. Recently given in Dubai, Nick's presentation outlines the key principles of monitoring your product's temperature, specifically discussing FDA, ICH, Design Qualification, and Operational Qualification, and many more terms in a digestible, and easily understandable way.
Transcript of Monitoring The Cold Chain: Proving You Kept Things Cold
Monitoring The Cold ChainNick Kovacic
Who is this talking to you?
•Name: Nick Kovacic
•Company: Dickson
•Occupation: Sales Manager
•8+ Years of Cold Chain Experience
•Hobbies: Golf, biking, my kid
Problem:
How do you prove you kept things cold?
HEP B
How are we going to figure that out?
Outline the issues
• FDA
• ICH
Describe key regulatory agencies
• Validation
• Qualification
• The 6 Key Principles
Discuss how to maintain the cold chain
First things first . . . sorry.
There isn’t one true recommendation on how to keep stuff cold.
WHO Guidelines on
the international
packaging and shipping of
vaccines
What do you do?
Vaccines
Two things stand out above the rest:
FMSAGMP
Title 21
Food Safety Modernization Act (FMSA)
Storage and Transportation of finished food should be protected against contamination and detonation.
GMP Title 21
Production Harvest Storage Transportation
Requires Comprehensive, service based, preventative controls across the food chain.
FDA ICH
FDA ICH
FDA ICH
Warehouse
V
Design Qualification
Operational Qualification
Performance Qualification
Validation
Design Qualification
Does the design or proposed design work and meet all requirements?
Example: A new refrigerator design is tested and qualified to ensure it can keep products within a particular temperature range before it is authorized.
BlueprintCompressorDoor Sealant
Thermal Insulation
Operational Qualification
Does the process or equipment perform at operational extremes?
Do all the processes or equipment operate correctly?
Performance Qualification
Does the process or equipment perform in a consistent manner over time?
12
3
6
9
6 Key Principles(Starting with #2 )
Principle #2: Be scientific.
Environment KnowledgeProduct Knowledge
Principle #3: Take tests.
Nick KovacicOctober 24, 2013
Warehouse Mapping Test
1. Problem Spot #12. West Mezzanine3. Office Door4. Refrigerator #145. Pallet Storage Area6. Roof7. HVAC8. Loading Dock9. Corner Logger10. Lunchroom
Principle #4: Document.
5.4C
5.4C
Doc #1
Product Storage and Handling Procedures
Principle #5: Understand your product’s path.
Field Warehouse Truck
Principle #6: Get documents from the path.
Temperature History
Loading . . .
A Common FDA Observation
“Your firm did not establish scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, product containers, in-process materials, and transport methods conform to appropriate stands of identity, strength, quality, and purity.”
Principle #1: Be complete.
Producer
Shipper
CarrierConsignee
Distributor
TESTED
DOCUMENTED
RECORDED
Who and what we talked about:
Regulators
• FMSA and GMP
• FDA and ICH
Validation
• Design Qualification
• Operational Qualification
• Performance Qualification
6 Key Principles
• Tested
• Documented
• Recorded
That’s how you keep things cold, that’s how
you keep things safe, and that’s how you don’t get
in trouble.
