Reexamining the Set It and Forget It Approach

BioPharm International, BioPharm International-09-01-2002, Volume 15, Issue 9

by Preston Poulter, Poulter Scientific, Inc. Process variations inevitably result in change, and change may mean new regulatory hoops. Statistical quality control is a cost-effective and efficient method for coping with change while still remaining compliant with 21 CFR Part 58.