Good Practice Guide: Booklet Labels


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Published: March 2013
Pages: 42

The pharmaceutical industry has been using fan-folded labels or booklet labels for many years, providing greater efficiency in production and reducing the cost of packaging and labeling. The use of booklet labels in clinical trials has become increasingly important in maintaining site and subject compliance.

The findings from risk assessments for using booklet labels for clinical trial materials were the subject of the ISPE Concept Paper on Booklet Labels. The paper also contains the results from an investigational site survey and pharmaceutical industry benchmarking. Using this information, the ISPE Guide Team developed this ISPE Good Practice Guide: Booklet Labels to present recommendations for using booklet labels in a standardized manner, helping to reduce or eliminate the risks and concerns expressed by the surveyed investigational sites and competent authorities.

Because booklet labels contain vital information for testing sites and subjects, this Guide promotes more consistent use of booklet labels to reduce confusion and non-compliance. It offers guidance on how to design and structure a booklet label and standardize their use and application. Additionally, it addresses the regulatory requirements of many countries and the practicability needs of the users with the goal of making booklet labels easy to follow and use. This Guide is the result of a joint effort of representatives from the pharmaceutical industry, with review by several pharmaceutical discussion groups and general support and professional insights from representatives of the MHRA (UK).

Additional information contained in the Guide includes designs for both secondary packaging and small primary packaging, as well as recommendations for booklet labels applied to IMP for use in hospitals (in-subject) and at-home treatments (out-subject). Special consideration is given for clinical trial materials labeled for multiple protocols, known as pooled products.