Does anyone know how PDA define the TOC limit for biopharmaceutical cleaning validation in its recent tech report #49? I have some difficulties to get the report version for the moment, but I need to know this part right now, can anyone help?
thanks in advance!
PDA has mentioned the TOC as one of the non-specific test methods for quantification of the residue. Calculate the content of carbon in your protein / product and convert it into a factor. Divide your TOC value with the factor which yields residue content. For Ex.: if your protein contains 25% carbon (1/4th) and your swab / rinse sample test result is 40 ppm. Hence, residue in your sample is 40 ppm x 4 = 160 ppm. However, it has mentioned about validation of TOC method as per ICH Q2
VEERRAJU
nvr.veeru@gmail.com
thanks Veerraju, your answer explain how to convert TOC to protein in the result. My question is: what is the acceptance limit for TOC, ie 500ppb/cm2, 5ppm/cm2 ? if there is no such acceptance criteria, how to make our own acceptance criteria?
The acceptance criteria never depends on test method / instrument. You need to derive it from your dosage quantities or toxicity data. Look at APIC’s “Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants” for the detailed explanation on calculation of acceptance criteria. Same method has been described in PDATR#49
VEERRAJU
nvr.veeru@gmail.com
Hi Veerraju,
Could you sent me a copy of this section of acceptance criteria of PDA TR#49? thanks a lot for help.
My dear friend, PDATR#49 is covered under copy right act. So, i cant share it here! SORRY
VEERRAJU
nvr.veeru@gmail.com