by The Law Library (Author)
Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA) is amending certain of its regulations on current good manufacturing practice (CGMP) requirements for finished pharmaceuticals as the culmination of the first phase of an incremental approach to modifying the CGMP regulations for these products. This rule revises CGMP requirements primarily concerning aseptic processing, verification of performance of operations by a second individual, and the use of asbestos filters. We are amending the regulations to modernize or clarify some of the requirements as well as to harmonize them with other FDA regulations and international CGMP standards. This book contains: - The complete text of the Amendments to the Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section