1.1 This standard covers terminology used by the E55 Committee relating to pharmaceutical and biopharmaceutical industry for manufacture of pharmaceutical and biopharmaceutical products. Terms ...

1.1 The purpose of this guide is to establish a framework and context for process understanding for pharmaceutical manufacturing using the principles of quality by design (QbD) (Juran, 1992; 2 ...

1.1 This guide introduces key concepts and principles to assist in the appropriate selection, development and operation of CM technologies for the manufacture of pharmaceutical products. Athough ...

1.1 This practice provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of ...

1.1 This guide is intended as a complement to Guide E2968 . It provides key concepts and principles to assist in the appropriate selection, development, and operation of continuous processing ...

1.1 This guide provides guidance on the development, validation, and implementation of advanced process control (APC) methodologies in a good manufacturing practice (GMP) pharmaceutical environment.

1.1 These test methods cover the determination of the radiopacity of materials and products utilizing X-ray based techniques, including fluoroscopy, angiography, CT (computed tomography), and DEXA ...