Zdrowie i gospodarka · 03/05/1996

Current Good Manufacturing Practice; Proposed Amendment of Certain Requirements for Finished Pharmaceuticals

The Food and Drug Administration (FDA) is proposing to amend certain requirements of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These amendments would clarify certain manufacturing, quality control, and documentation requirements and would ensure that the regulations more accurately encompass CGMP. In addition, the agency is updating the requirements for process and methods validation to incorporate guidance previously issued to industry and to reflect current practice. These proposed amendments are intended to enhance the integrity of the drug manufacturing process and the safety of drug products.