Cleaning validation after peptide production

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

Hello,
I’d like to find out what is the recommended method for calculating limits for cleaning validation after production of peptides by chemical synthesis.
should I use limit calculations based on therapeutic data / toxicological data (as for small molecules APIs), or should I use the 10ppm limit per sample, which is the common practice for cleaning validation in biotech bulk manufacturing?
(The analytical method used is a TOC method in order to detect degradation products as well as API residues)
I’ll be happy to hear some suggestions

Thank u

2

The EMA and FDA are expecting companies to use toxicological and pharmacological data to determine a health-based limit. They are not accepting the 10 ppm or or some fraction of the low clinical dose as a limiting setting method. .EMA just published a draft guidance (the comment period just closed) where they clearly state that 10 ppm and 1/100th of a low clinical dose are not acceptable and toxicological and pharmacological data must be used to set a threshold value. Here is the link

http://www.ema.europa.eu/docs/en_GB/...C500137091.pdf