Refrigerated Shipment - GMP SOP

Good distribution practice is one of the key elements of a successful business today, particularly when it comes to the transportation of pharmaceuticals that require cold shipment.

This Standard Operating Procedure (SOP) is applicable for facilities that receive/ship refrigerated products by truck or plane that must be stored at temperatures between 2 C to 8 C.

The 8-page Standard Operating Procedure (SOP) describes processes, responsibilities and accountabilities and needs only a small amount of site-specific modification before it can be used for your operations.

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Description

Table of Content

1. Regulatory Basis, Reference Documents
2. Purpose
3. Scope
4. Responsibilities and Accountabilities
4.1 Supply Chain
4.2 Warehouse personnel
4.3 Quality Head
5. Procedure
5.1 General
5.2. Description of the Transportation chain
5.2 Air Freight
5.3 Thermo Truck
5.4 Shipment duration
5.4.1 Shipment within (24) hours
5.4.2 Shipment within (72) hours
5.5 Shipment Qualification
6. Deviations
7. Changes
8. Definitions
9. Distribution
Attachment 1: Checklist shipping with thermo truck (+2°C to +8°C)

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SKU Refrigerated Shipment - GMP SOP

FDA-EMA

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Delivery item: Word Document
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Please note: We do not deliver hard copies.


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