We buy bulk tablets, and pack them under the name of our Company. Bulk manufacturer batch size is, lets say, 1 000 000 tablets, given in registration dosier, which we submited in our Agency. Now, we decide to buy 1 000 000 tablets (one lot) every time, but we decide to pack it for example in batches of 330 000 tablets (for example 11 000 boxes), 660 000 tablets (22 000 boxes) or 990 000 tablets (33 000 boxes), depending on the Markets. My question is, do I need to validate primary and secondary packaging of all 3 batch sizes (pack sizes)? And what IS the batch size for me, bulk manufacturer lot of 1 000 000 tablets, or batch sizes we are going to do here in our Company? Do I present batch size in tablets or number of finished products (boxes)? Hope you can help me…
Well, I’m not an expert in this area, but I’ll give you my thoughts. The bulk manfacturer does not set the final dosage batch size, that is done by the final manufacturer. The batch size you establish is what you validate. A question: What are the parameters your validating for batch size and how do they affect the product? Do you have an MVP that addresses batch size validation, and what does it say? Is your container amt. the same for every box (is this the package enclosure, not sure what you mean by “box”. Experts will experience in this area please jump in!!