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Establishing Limits

Hi. someone can help provide some sources where you can find NOEL values?
Furthermore, Which approach do you recommend for estimating limits? NOEL, NOAEL, LOEL or some other?
Regards!

Acceptance limits are based on the NOAEL (no observed adverse effect level) not NOEL, thus the ADE (acceptable daily exposure). The ADE can be found in clinicals II or www.affygility.com Always use a registered toxicologist to determine the ADE or PDE in Europe (same concept)!

Always use (or adapt with justification) APIC 2014 equations!

Thank You Boomer, can you give me any example for How you can estimate the NOAEL for Cefuroxime Axetil?
Or What can you do when there not avalible data on literature?
Regards!

Cephlasporin and it’s analogs (like Ceftin) MUST be manufactured in a ‘dedicated’ (not shared and thus no MACO) facility (like Penicillin) since people become sensitized to very low residues. See 200.65 (I think)!

We had a separate Cephlasporin building at King Pharmaceuticals in Rochester.

See this. Cephlasporins must meet the same manufacturing criteria as Penicillin. See the regulators for their opinion.

http://www.cleaningvalidation.com/Resources/CGMP/June1998.aspx

You can also read this article.