ISPE Publishes White Paper on "Dedicated Facilities"

GMP News
5 September 2007

ISPE Publishes White Paper on "Dedicated Facilities"

The GMP News from 11 March 2005 focused on a Concept Paper from the European Commission regarding "Dedicated Facilities".
Responding to this Concept Paper a Task Team of the International Society of Pharmaceutical Engineering (ISPE) published a "White Paper" to introduce its perspective on "Dedicated Facilities" and to gain more influence on the Concept Paper's further development.
Key of the White Paper is the use of a "scientific risk-based approach" to define whether "segregation or dedication" of facilities is necessary. Here it explicitly refers to ICH Q9 (Quality Risk Management).
In ISPE's opinion risk assessment should be strongly geared to the ADI (Acceptable Daily Intake-) value of the relevant substances and not only to defined product classes, definitions or warnings on labels. ISPE summarises its view in the formula Hazard x Exposure = Risk.
"Risk Assessment" should then be the basis for the management of "risk control". That means "Risk Assessment" leads to criteria that build a rationale for the monitoring and "Risk Control" as well as for cleaning and "acceptable carry over levels". Completely or partially "dedicated" or "segregated" facilities may be required if the respective data for cleaning and "acceptable carry over levels" are not met. In this regard "One fits all" is not an option for ISPE. The organisation rather clearly prefers the option to implement this individually.
In addition to a suitable design of facilities and equipment SOPs are also factors minimizing the risk.
ISPE concludes that "dedicated" or "segregated" facilities are only necessary, if physical organisational measures and/or a cleaning procedure do not prevent cross contamination to an acceptable level.
The organisation also stresses that the protection of personnel and products have to be equal and that over-emphasising the one side can possibly lead to neglecting the other.
Cleaning is a separate chapter in the White Paper. ISPE concludes that "Dedicated Facilities" are only necessary if cleaning procedures do not ensure an appropriate depletion (cleaning validation) for avoiding cross contamination.
The White Paper ends with the announcement that in the future Guidelines regarding Risk Assessment, Risk Management and Facility Design will be developed in liaison with industry and authorities.
The White Paper is available in the Internet at

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Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

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