Retention of Costly and Large Size FG retention samples of Veterinary Product

Quality Assurance
1

In routine QC collect 1 FG test sample & 1 FG retention sample from each Finished batch of Oral Powder of Veterinary Products.
In veterinary the Pack size is large 1Kg, 5Kg and onward and also each pack is very costly i.e. 1Kg pack cost is in 20K or 30K etc.
Is it allowed to take 1 FG sample and QC draw sample from this sampled FG pack for testing and remaining pack immediately sealed and kept as Retention sample.
So instead of taking 2 samples, 1 sample is sufficient?

Please Guide

2

I can suggest you sample the final product from the bulk powder just before filling and packing to avoid collection of the final pack OR to avoid opening the retention sample pack.
You can do other tests from the final packs during packing operation such as sealing quality, Batch coding verification, and weight check of powder in each pack as a part of QC/IPQC checks.
This will avoid unnecessary opening of the final retention pack for QC testing purposes. You can specify this procedure in the internal SOP.

1 Like
3

THANKS FOR REPLY. It seems logical.

4

You are always welcome.

5

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