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.