C
I need help!
I'm trying to establish a reduced testing plan for raw materials involved in the production of API (Active Pharmaceutical Ingredients).
I've done some online research and have tracked down some possibilities. The term skip-lot testing keeps popping up but I can't seem to determine if it's a viable option as far as the FDA is concerned.
I'm also confused as to whether our current sampling plan (square root of N+1) can be used with skip-lot testing.
I'd really appreciate any help anyone would be able to offer.
I'm trying to establish a reduced testing plan for raw materials involved in the production of API (Active Pharmaceutical Ingredients).
I've done some online research and have tracked down some possibilities. The term skip-lot testing keeps popping up but I can't seem to determine if it's a viable option as far as the FDA is concerned.
I'm also confused as to whether our current sampling plan (square root of N+1) can be used with skip-lot testing.
I'd really appreciate any help anyone would be able to offer.