NOEL and MACO for non human products

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hi,

Could you please help me with one problem:

How can I calculate NOEL and MACO for non human products. To be clear: in all documents about cleaning validation I found this formula for NOEL:

NOEL=LD50 x 70kg/2 000, where 70kg is average weight of an adult. But which weight I have to insert in NOEL formula, when my products are for animals (pigs, cows, horses, dogs…).
And what I have to do when one product is used in healing for many types of animals with difrent average weight. Do I have to use a smallest average weight (average weight for smallest animal) and in MACO formula use therapeutic daily dose for that animal.

Thank you in advance for helping me.

Slavica

2

Hi everyone,

Is it possible that no one can/ want to tell me any sugestions about my previus post.

Please help me.

Slavica

3

You can calculate NOEL and MACO for non human products. if your product for multi animals then
in NOEL calculation you should go with small adult animals average weight because in NOEL calculation LD50 is used.

in MACO calculation you should use standard therapeutic daily dose of higher animals daily dose.

Huma Ali

4

Huma Ali thank you very much for this information. It was very helpful.

Slavica