Sasha Latypova on Substack: "Technical fine point: the facility can be cGMP compliant, but that does not mean the specific product is cGMP compliant. The reference to “cGMP compliant facilities” is another set of words designed to deceive the reader. cGMP compliance for pharmaceutical product means the pr…"

Technical fine point: the facility can be cGMP compliant, but that does not mean the specific product is cGMP compliant. The reference to “cGMP compliant facilities” is another set of words designed to deceive the reader. cGMP compliance for pharmaceutical product means the process of making that specific product, it’s raw materials and all quality control steps are certified compliant. I believe that the DOD is sending “black box” components to be assembled by pharma in pharmaceutical manufacturing places but pharmas themselves (especially employees on the manufacturing line) probably do not have good idea or traceability of what those components are.

I have seen provisions in the Dec. 11, 2020 (Pfizer) and Dec. 18, 2020 (Moderna) Federal Register notices by Rear Admiral Denise Hinton, that could be construed as requiring cGMP compliance. See Section III, Item I, Conditions of Authorization, at p. 8/20 for Pfizer Letter of Authorization, and Section III, Item I, Conditions of Authorization, at p. 17/20 for Moderna. The provisions look like this: These provisions can only be construed as requiring cGMP compliance, if observers ignore the knowledge painfully gained from Brook Jackson’s whistleblower case: that there are public-facing contracts and regulatory documents listing otherwise applicable terms and conditions, and also as-yet-undisclosed contracts, authorizations, notices and other regulatory documents that nullify, void, waive, limit or authorize deviation from the otherwise-applicable, otherwise-enforceable terms and conditions in the public-facing documents, rendering them inapplicable and unenforceable.

Katherine Watt

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Oct 26, 2023