Zdrowie i gospodarka · 02/10/2006

FDA Releases Guidance on Pharmaceutical Quality Systems Approach to CGMP Regulations

The Food and Drug Administration (FDA) has made available a guidance document outlining its current thinking on advances in quality and manufacturing sciences since the issuance of the Current Good Manufacturing Practice (CGMP) regulations in 1978, and how companies can implement a robust quality systems model to achieve compliance with these regulations.