Thursday, June 29, 2023 12:58:09 PM
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.
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