ISPE, the International Society for Pharmaceutical Engineering was founded in 1980. It is the world’s largest non-profit association which aims to provide its members with leading technical, scientific and regulatory advancement throughout the entire pharmaceutical life cycle. The ISPE has headquarters based worldwide, including Tampa, Florida, USA and also in Brussels, Singapore and Shanghai.
The organisation consists of 20,000 members who work to find solutions in the development and manufacture of safe and effective pharmaceutical and biological medicines and medical delivery devices to more than 90 different countries. The ISPE has recently helped to publish guidelines for companies to standardise the use of booklet labels for those conducting clinical trials.
The ISPE President and CEO Nancy Berg said, "Companies involved in clinical trials now have a resource that provides guidance on ow to design and structure a booklet label and ow to standardise the use and application of booklet labels for global clinical trials."
“By following the recommendations presented in the guide, companies can feel confident that their booklet label strategy is supported by a scientific, risk-based methodology and patients are receiving accurate, complete instructions in their local language.”
ISPE has said that they hope that the new recommendations will help companies determine the gaps between their best practises and their current booklet label procedures. The guide was written to create methods for standardising the design, content and format of clinical trial booklet labels to enable more consistent use and reduce any confusion.
The new guide, the ISPE Good Practise Guide: Booklet Labels will act as a valuable tool to perform a gap analysis on current processes and readdress them in order to:
Eliminate/reduce and concerns or risks addressed by regulators or sites
Increase operational efficiency while ensuring the safety of the subject
Reduce errors in the design process, reduce the distribution delay process and allow for printing standardisation
Reduce the sites dispensing errors
Allow both staff and subjects to become familiar with label design
Allow for standardised training of both the subjects and sites in product handling, Use- by-dates and use of booklet labels
Reduce delays and costs due to destruction or re-labelling for products with extended expiry dates
The new guide is available to purchase from the ISPE website www.ISPE.org.
