Supplement to OECD Document #17

Action required

Take note of the updated Good Laboratory Practice Program (GLP) document from the Organisation for Economic Co-operation and Development (OECD).

Affected customers

SCC GLP-recognized facilities, applicants, and inspectors.

Background

The OECD has published Supplement 1 (PDF) to Document Number 17 (PDF) on the Application of GLP Principles to Computerized Systems.

An increasing number of GLP test facilities use cloud applications to accommodate requirements with regard to data quality, data integrity and data availability and retention. It is important to address any potential repercussions on GLP compliance when utilizing cloud-based solutions. The new document was developed by Belgium and France (Medical Products) to provide more information on the use of cloud-based systems.

New requirements

None

Deadline

None

Questions?

Please contact Vivekananthan Kulasingham, Manager, Compliance and Assessment Services, at vivekananthan.kulasingham@scc-ccn.ca or +1 613 238 3222 for more information.