An MD&DI February 1997 Feature Article
FDA Makes Quality the Rule (continued)
7. CORRECTIVE AND PREVENTIVE ACTION
Required activities related to corrective and preventive action are described in subpart J of the new regulation. FDA has, for a number of years, interpreted section 820.20(a)(3) of the 1978 GMP regulation as requiring controls that are now actually spelled out. The new rule makes it clear that manufacturers must have a program for monitoring sources of quality data (whether generated internally or externally), for trending the data, and for acting on the trends. The results of the corrective and preventive action program must be reviewed as part of the management review required by 820.20(c).
Documentation of data, and the trending of them, will be a fertile area for FDA investigators who are seeking to identify problems and determine whether a firm has made proper corrections. The requirements of this section have not changed from those proposed in the 1995 working draft.
