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Thursday, December 18, 2025 1:46:17 PM
"We generally require that the commercial manufacturing process intended for the MA be fully qualified, GMP- compliant, and reflected in the Manufacturers License before the MA is granted.
MHRA will typically assess the updated process as opposed to the original, especially if the applicant intends to commercialise the new route.
Timeline impacts are usually considered clock-stops, not backlog.
We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.
The MA must reflect the commercial manufacturing route."
The manual process IS "fully qualified, GMP-compliant and reflected in the Manufacturers License".
The manual process IS "the original", and the applicant INTENDS "to commercialize" it.
The manual process IS "the original process".
The MA DOES "reflect the commercial manufacturing route", which is the manual process.
You are taking their statement and twisting it around to correlate with your (false) insistence that you are right and the vast majority of the rest of us, including those who are familiar with the inner workings of the company, are wrong. You have a pathological need to always "win".
MHRA will typically assess the updated process as opposed to the original, especially if the applicant intends to commercialise the new route.
Timeline impacts are usually considered clock-stops, not backlog.
We generally cannot grant an MA based solely on the original process if the applicant no longer intends to use it.
The MA must reflect the commercial manufacturing route."
The manual process IS "fully qualified, GMP-compliant and reflected in the Manufacturers License".
The manual process IS "the original", and the applicant INTENDS "to commercialize" it.
The manual process IS "the original process".
The MA DOES "reflect the commercial manufacturing route", which is the manual process.
You are taking their statement and twisting it around to correlate with your (false) insistence that you are right and the vast majority of the rest of us, including those who are familiar with the inner workings of the company, are wrong. You have a pathological need to always "win".
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