Dear Members,
For a non-sterile intermediate intended for use in a sterile API drug , what level of equipment cleaning or sanitization and/or sterilization is expected ?
Is there any need to check BET for the non sterile intermediate ?
Thanks
Satyavijayarao
Dear Mr. Satya…
your question needs elaborations.
Are you the manufacturer of intermediate only or API also?
If you are the supplier of non-sterile intermediate to a sterile API manufacturer, no need to test BET since your intermediate is non-sterile. But, if your customer asks to produce the BET test report, you have to produce the same, to keep your customer with you. Same case for sanitization / sterilization.
The level of cleaning depends not only on previous product (intermediate). it also depends on next product. if you are manufacturing only non-sterile intermediates in your site, up to 1000 ppm (0.1%) of previous product can be allowed as permissible limit (ICH Q3A indicates that up to 0.1% of an individual impurity may be present in the product being tested)
But, if you are manufacturing intermediates and APIs in same site, maximum-allowable-carry-over (MACO) / No-Observed-Effect-Level (NOEL) can be calculated by applying suitable safety factor, and same can be used as permissible limit.