Please elaborate the definition of dedicated equipment. Equipment used on a campaign during six months can be considered dedicated during this period. Does cleaning validation apply if change of product is forecasted?

Dedicated means that it is used solely for one product and only this product is manufactured in
this equipment. In the case of the six-month campaign, it’s still a multi-purpose facility. As per
Section 5.2, equipment assigned to continuous production or campaign production “should be
cleaned at appropriate intervals to prevent build-up and carry-over of contaminants (e.g.,
degradants or objectionable levels of microorganisms).” It is up to the company to define the
appropriate intervals for cleaning equipment. During this six-month campaign, there may have
been cleaning between batches, in addition, appropriate cleaning should be conducted after the
campaign is finished to prevent cross-contamination. It would also be appropriate to consider
validation of the cleaning at the end of the campaign.