The authors relay the outcome of a two-day workshop that brought together regulators and generic-drug industry representatives. The US Food and Drug Administration's Office of Generic Drugs (OGD) and ...

The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs. Identifying potential ...

Customers enjoy buying from a small business that consistently delivers great products. However, the experience may last only a short time: Only two out of four small businesses survive beyond five ...

Improving the quality of clinical trials is a major strategic activity for Big Pharma, one where efficient management of a demanding set of regulatory requirements can have a positive impact on the ...

The manufacturing industry saw significant improvement in quality within the last few decades due to the implementation of Lean Manufacturing process and Six Sigma quality control measures. Lean ...

A Protection and Control (P&C) design package for a typical substation includes a number of interrelated drawings, including one-line diagrams, schematic diagrams, wiring diagrams and interconnection ...