Master Plans

Qualification master plan for refrigerated shipment

Master Plans
185,00 EUR
app. 244.20USD
(Non-german customers)

220,15 EUR
(German customers incl. 19% tax)



FDA
EMA
What you will get:
Delivery item: Word Document
You will be able to enter your data into the Word document.
Please note: We do not deliver hard copies.
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Description of the Master Plans - Qualification master plan for refrigerated shipment

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

Qualification master plan for refrigerated shipment
185,00 EUR
Additional 19% tax for customers from Germany
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