In response to the EMEA’s February 2005 “Concept Paper Dealing with the Need for Updated GMP Guidance Concerning Dedicated Manufacturing Facilities in the Manufacture of Certain Medicinal Products,” ISPE issued a white paper to the EMEA in early March. The white paper endorses the risk-based approach advocated by EFPIA. ISPE, which has been supporting the approach since April 2005, has formed a task team to continue working with and educating the FDA on developing industry guidelines on risk assessment, risk management, and facility design for highly hazardous compounds in the US.

Download the White Paper  (PDF,  47 KB)