ISPE Good Practice Guide: Booklet Labels

Handbook / Manual / Guide by International Society for Pharmaceutical Engineering, 03/01/2013

Full Description

This Guide was written to create methods for standardizing the format, design and content of clinical trial booklet labels. Because booklet labels contain vital information for testing sites and subjects, the Guide enables more consistent use of booklet labels to reduce confusion and non-compliance.

In addition to suggestions for effective and compliant booklet label design, the ISPE Good Practice Guide: Booklet Labels includes recommendations and justification for placement of required information and whether it should be included on the label or elsewhere. This Guide is a valuable tool you can use to perform a gap analysis on your current processes and readdress them to:Reduce/eliminate risks and concerns addressed by sites and regulatorsIncrease operational efficiency while ensuring subject safetyReduce errors in design process, allow for printing standardization and reduce delays during distribution processReduce dispensing errors by sitesAllow subjects and staff to become familiar with label design, so they know where to look for informationAllow for standardized training of sites and subjects in product handling, use of booklet labels and Use-by dates.Reduce costs and delays due to destruction or re-labeling for products with extended expiry dates

Product Details

Published: 03/01/2013 ISBN(s): 9781936379583 Number of Pages: 42 File Size: 1 file , 1.6 MB