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hyperopia

06/29/23 12:58 PM

#605640 RE: flipper44 #605617

Okay flipper, that is exactly what I thought. You seem to be misinterpreting the part you highlighted “And it can take as much as 30 hours for a qualified person to release a product.” to mean how long it takes for final product testing, but that’s not what that means.

The final product is tested for identity, purity, potency, and stability against pre-established release criteria for the product. And then as I just said, there are a number of additional tests (sterility, endotoxin, mycoplasma) to ensure that the product contains no contaminants. All of this testing takes about a month or more.

And then after all that, but before the product can be released to a patient in the UK, a qualified person (QP) must review all the manufacturing, quality assurance, and quality control data. This is the part that Linda was discussing in your highlighted text. It could take up to a few days for a qualified person to review all of the hundreds of pages of manufacturing data to ensure the product is safe to be released to the patient.