A colleague of the authors suggested a test of the end-of-line weighing station during packing-process validation by moving
several MUBs along the line with one leaflet missing from each. The authors stand by the original concept followed in this
study. Key process components must be qualified before the packing line is validated as a whole. The process is validated
by integrating all qualified components and simulating normal process function as closely as possible without compromising
the regular course of the process by adding an extra challenge. The authors believe that the technical balance's sensitivity
for detecting missing components should be determined in advance. Then, one can focus on the objective of process validation,
which is to evaluate the packing operator's ability to deliver completed MUBs throughout the simulation runs. Nevertheless,
the above suggestion could be analyzed in a further revalidation of justified in-process changes.
Arturo Toledo Rivero* is the head of the research and development department, Nelson Sierra Prado is the head of the validation group, and Yohann Pérez Molina is a quality engineering specialist at LIORAD Laboratories, Ave. 27A No. 26402, La Lisa, Havana, Cuba, tel. 1537 2717935,
fax 1537 2717899, firstname.lastname@example.org
Ian Toledo de Zayas is a logistics specialist at DUJO Business Group.
*To whom all correspondence should be addressed.
Submitted: Aug. 8, 2007. Accepted: Nov. 1, 2007.
1. European Commission, "Production", in Volume 4—Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice, (European Commission, Brussels, Belgium, 2005), pp. 47–49.
2. ISPE, "ISPE Baseline Guide—Packaging, Labeling, and Warehousing," (ISPE, Tampa, FL, vol. 7, rev. B, 2005).