Current Situation - FDA Report
The need for a modern approach to managing quality in the pharmaceutical industry was first identified by the US Food and Drug Administration (FDA) in their September 2004 report: ‘Pharmaceutical current Good Manufacturing Practices for the 21st century – a risk based approach’.
Click here for more information from the report.
The report recognised that in the past, the FDA had exercised extensive control over virtually every aspect of the manufacturing process. This led pharmaceutical companies to concentrate their quality assurance activities on compliance with regulations.
This approach made pharmaceutical companies reluctant to innovate because of perceived and sometimes real regulatory hurdles.
