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My company recently took ownership of a medical device product. This product is manufactured in two parts that are later packaged together as a kit. Our plan is to switch the manufacturing of one of those parts (a biologic in a syringe) to our manufacturing site. As part of this process we are planning on manufacturing product for stability.
Our management representative (the Director of Quality) has stated that he would like 3 lots of product for stability. The problem is that the VP of Manufacturing is objecting. The VP of Manufacturing feels, based on the fact that the FDA doesn't require 3 batches, that only one batch is required by the FDA for a change in manufacturing site. The VP further stated that "It doesn't matter what [the Management Representative] thinks."
Does anyone have any opinions on what the FDA would normally be look for? Couldn't only one batch pose a possible delay to the site transfer?
Our management representative (the Director of Quality) has stated that he would like 3 lots of product for stability. The problem is that the VP of Manufacturing is objecting. The VP of Manufacturing feels, based on the fact that the FDA doesn't require 3 batches, that only one batch is required by the FDA for a change in manufacturing site. The VP further stated that "It doesn't matter what [the Management Representative] thinks."
Does anyone have any opinions on what the FDA would normally be look for? Couldn't only one batch pose a possible delay to the site transfer?

