This is the part i don't understand. I would have thought that the tga would provide guidance on what they require in a submission. Given that the test kits are an integral part of the process would they not have said that they need evidence of the manufacturers ability to maintain quality control across production runs. I just dont get it and feel theres not been total honesty about this.
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- Ann: Update to TGA Submission
Ann: Update to TGA Submission, page-97
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