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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
http://www.ispe.org/galleries/e-letter-files/EMEA_white_paper.pdf
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