Recalled Paracetamol, a question for CMC gurus [Off Topic]

posted by ElMaestro  – Belgium?, 2019-06-19 17:10 (490 d 01:05 ago) – Posting: # 20349
Views: 3,577

Hi nobody and Hötzi,

» » Wouldn't that be shocking? Some kind of... ...hhhmmmm.... fraught? 8-O


Yes I find it highly misleading, too.

» Acc. to EEA legislation: Manufactured in country A → released by a “qualified person” in European county B → officially manufactured in B. That’s it. Correct me if I’m wrong.

That is exactly what it means.
I will be interviewed about such matters next week by a journalist who is sick and tired of some of the garbage we have to suffer in EU because the rules and regulations may be perceived as totally obscure and very much intended to protect regulators rather than patients.

What's more, you can't ask your doctor or at the pharmacy. They don't have such info either. For example,
"I don't want a Valsartan product where the active ingredient is from China because I heard it may be contaminated with carcinogens." - noone can help.
"I don't want a product manufactured in India, regardless of where it is released" - noone can help.
"I don't want a product approved on basis of a BE study done at GVK Bio or Semler" - noone can help.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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