ABSTRACT
SUMMARY: The Food and Drug Adm in istration (F D A ) is p roposing to am end
certa in requ irem ents o f the current good m anufacturing practice (C G M P) reg ulations for fin ished pharm aceuticals. T h ese am endm ents wou ld c la rify cer tain manufacturing, qu a lity control, and docum entation requ irem ents and
wou ld ensure that the regu lations m ore accurate ly encom pass CGMP. In addi tion, the agen cy is updating the requ irem ents for process and m ethods va lida tion to in corporate gu idance p rev iou s ly issued to industry and to reflect current practice. T hese p roposed am endm ents are intended to enhance the in tegrity o f the drug m anufacturing process and the sa fety o f drug products.
