Description

Have you thought about qualifying your cold chain transportation? Professional cold chain management practices are vital for ensuring product quality and patient safety.

We have compiled a 10-page qualification master plan that is available for all customers operating in a GMP and Good Distribution Practices (GDP) environment.

The ready-to-use qualification master plan for refrigerated shipment helps you to set up your qualification procedures. The master plan includes a 6-page protocol template and a 6-page report template, both of which need only a small amount of site-specific modification before you start your cold shipment transportation qualification.

Table of Contents:

1. Purpose
2. Qualification Team
3. Description of the Transportation chain
4. Critical parameter
5. Risk Assessment
5. Qualification Protocol
Attachment 1: Qualification Protocol:
1. Description
2. Test
3. Acceptance criteria
4. Test results
5. Test conclusion
Attachment 1: Position of Temperature Recorders
Attachment 2: Qualification Report:
1. Purpose
2. Qualification Team
3. Documentation
4. Description of the Transportation chain for run #1, #2, #3
4. Summary of individual Transport tests
4.1 Run 1
4.2 Run 2
4.3 Run 3
5. Deviations
6. Conclusion
Attachment 3: Specifications and description of used container type I
Attachment 4: Specifications and description of used container type II
Attachment 5: Specifications and description of used data logger
Attachment 6: Real life field test
Attachment 7: Dry Ice Characteristics