ISPE Good Practice Guide: Clinical Supply Systems PDF

Currently there are no standards or guidelines for system functionality that manage Investigational Medicinal Products (IMPs). Lack of standards for data and functionality has resulted in varying terminology, data formats, and controls which can often make the selection, use or interfacing of systems challenging.

This Guide, the ISPE Good Practice Guide (GPG): Clinical Supply Systems, contains a list of proposed standard data terminology, as well as equivalent terms which are frequently used, definitions of the data items, and data formatting standards.

The Guide also provides a detailed discussion of important areas of clinical supply system functionality touching on key business requirements to assist interested parties in developing customized clinical supply applications and/or assessing COTS sytems for implementation. Examples and requirements for interfacing clinical supply systems involved in the mangement of IMPs with other internal or external systems is provided.

This Guide will be useful for individuals with a foundational background in clinical supplies, who are involved in evaluating or designing clinical supply systems which meet operational, quality and regulatory requirements.

This Guide also may be useful to personnel in smaller biopharmaceutical organizations to assess the systems that their suppliers use to support the clinical supply services they provide. This Guide is also meant to help companies adopt common data standards to make working across company boundaries more seamless.

It is important to note that this document is a Guide. Each company should determine requirements for their systems based on business priorities and their interpretation of current regulatory and quality requirements.