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Post# of 822671
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dennisdave

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dennisdave

Re: flipper44 post# 804846

Sunday, 12/28/2025 3:51:55 PM

Sunday, December 28, 2025 3:51:55 PM

Post# of 822671
You really are clueless as per usual. haha
I’m not ignoring anything. I’m distinguishing what they are from and what they are not from. Yes, the 2025 regs introduce two formal pre-requirements, but they are regulatory assessment gates, not certifications of equipment design. Neither the Designation Step nor the Design Step results in a GMP-approved or “stamped” machine. They assess justification and framework, not validated performance. GMP approval still only follows physical installation, IQ/OQ/PQ, and comparability.

How is your 10-year data doing, Flipper 😂
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