Zdrowie i gospodarka · 4.12.2007
Current Good Manufacturing Practice; Amendment of Certain Requirements For Finished Pharmaceuticals; Withdrawal
The Food and Drug Administration (FDA) is announcing the withdrawal of a proposed rule published in the Federal Register of May 3, 1996 (61 FR 20103) (the May 1996 proposed rule). The May 1996 proposed rule would have amended certain requirements of the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These proposed changes would have clarified certain manufacturing, quality control, and documentation requirements and would have updated the requirements for process and methods validation. In light of more recent scientific and technical advances and evolving quality systems and risk management concepts, FDA concludes that, at this time, it is appropriate to withdraw the May 1996 proposed rule and newly evaluate the issues raised in that proposal.