MACO limit from ALD

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hi Guys
I have to determine MACO carryover limits for a multi product facility.
For one API, I have NOEL and LOAEL toxicity values,
For the second API, I have an ALD (approx lethal dose) tox value.
Does anyone know how to use the ALD value to generate a MACO limit?
Thanks

2

APIC guideline for cleaning will provide required information

3

Unfortunately APIC does not cover this, been down that avenue

4

Ok than calculate with tdd or based on toxicity or 10 ppm criteria and cosider lowest value as MACO

5

cleman

We have developed a MACO calculation software (www.eresidue.com) that addresses requirements of multi-product facilities. Just feed in the equipment and the product data and the application spits out a report. I can do a quick online demo, if this would be of interest to you.

6

Hi Cleman,

We do not support direct advertising on the forum…if you would like to take out an advert with us please contact me directly.

Regards

7

Graham
Its my mistake. Not cleman’s. Will keep that in mind from now onwards.

8

No problem @rmoorthy1 all good.

9

Using NOEL or ALD in no longer acceptable. It must be ADE (acceptable daily exposure, a function of toxicity). See Chapters 3 and 5 of the Eudralex.

10

In both cases you should use the ADE (a measure of toxicity derived from the NOAEL). Perform a ‘risk analysis’ and select the lowest ADE. Remember, it is your ‘cleaning procedures’ which are being evaluated using the MSC (maximum safe concentration, the new MACO) as a yardstick. See chapters 3 and 5 of the Eudralex.

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