Are multi-product facilities expected to come up with various PDE limits and toxicological risk reports?
http://ec.europa.eu/health/files/gmp/2013_gmp_pc_en.pdf
Hello,
The new guidance replaces the more generic practice in how carryover maximum limits are set (10 ppm or 1/1000 of clinical dose, which ever is lowest) to ensure the potential toxicity of the residual drug is more fully considered (to ensure that there are not some toxicities such as allergies or reproductive effects, that could occur even at 1/1000 of the clinical dose). I cannot say how this guidance might be enforced, since that is not my field, but to determine the drug PDE and to prepare a brief risk assessment report supporting the limit should hopefully not be too onerous since toxicology and clinical safety data should be available for most drugs for them to have been approved for patient use. There should be investigator's brochures (if innovator), product monographs, and published information available that you can request. I would suggest having a report available for every drug produced using shared facilities. Also prepare a spreadsheet or other tool with the maximum daily dose of each of your drugs that allows you to easily calculate the concentration of drug B, C, D, etc. in drug A that would be below the PDE of drug B, C, D, etc. when drug A is taken at the maximum daily dose. Do this same exercise for all of your drugs.
I hope this information is somewhat helpful.
Best Regards
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