Manufacturing of Potent drugs- What are regulatory expectations on preventing cross contamination?


Whether ICH Q7 or 21 CFR expectations to avoid cross contamination are only mentioned with respect to penicillin products.

In April 2013 FDA also published guidance on cGMP framework for preventing cross contamination of Non penicillin beta lactums.  This guidance describes the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam drugs.

This guidance mentions the expectations that manufacturers should utilize separate facilities for the manufacture of non-penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity.

When it comes to other potent drugs there is no clear guidance on expectations of equipment’s used, facility design etc  to avoid cross contamination and it is industry practice to normally apply the controls similar to what are mentioned for pencillin facilities to avoid cross contamination.

For contract manufacturing multiproduct facilities it may become a huge investment to make separate facilities for potent drug products with respect to buildings and HVACs .

ISPE Baseline Guide on Risk based manufacture of the pharmaceuticals mentions that there are numerous reasons to dedicate a facility for potent drug for ex product specific audits, may require unique product specific technology, etc. However if cleaning technology, feasibility, cost practicability and potential risk to patient is evaluated and if all these parameters are satisfactorily meeting the risk based decision to use multiproduct facility may be taken by the manufacturer but if the answer is “No” i.e. if the expectations are not meeting satisfactorily the most viable option is to use only dedicated facility for manufacturing a potent drug product.

Normally the manufacturers choose the option of using  dedicated facility for potent drugs so as  the safest mechanism but ISPE guide is valuable to take  risk based decisions on whether or not multiproduct facility can be used for such manufacturing.

For any queries on prevention of cross contamination from potent drug facility, FDA expectations and, compliance to regulatory inspection for cross contamination related observations, Source Consulting team of highly experienced pharma professionals is  always available to help our clientsWhether ICH Q7 or 21 CFR expectations to avoid cross contamination are only mentioned with respect to penicillin products.

For more details you may contact Sourceconsulting team.

01 Jan 2018