There is no specific rule for different pack size numbers to be filled.
The best approach is try to fill the minimum number of bottles/blisters that allow feasibility of the automation and FDA can rely on your packaging operation. To achieve this try to equalize the all different configuration bottles i.e. 300 bottles of 30 count, 300 bottles of 60 count, 300 bottles of 90 count and 5,000 blisters.
You may choose from available materials and costing as well when you select the number of different configuration.
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Gaurang Bhavsar, MS, RAC
Scientist-II, R&D and RA
Sunrise Pharmaceutical, Inc.
Rahway, NJ 07065
USA
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Original Message:
Sent: 07-Nov-2017 10:45
From: Mehul Govani
Subject: Packaging test batches
Hello All,
Are there any specific requirements regarding how the ANDA test batch is split with regards to packaging. For example: If a product is packaged in blisters and also in 3 different bottle sizes (30, 60 and 90 count), should a test batch (100,000 units) be split equally among all four configurations?
Thanks,
Mehul
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Mehul Govani RAC
Regulatory Affairs Manager
PL Developments
Westbury NY
United States
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