OECD Advisory Document on GLP Data Integrity (No. 22)

Action required

All SCC recognized and applicant facilities and Good Laboratory Practice Program inspectors to take note of the new Organisation for Economic Co-operation and Development (OECD) Advisory Document on GLP Data Integrity (No. 22).

Affected customers

SCC GLP recognized and applicant facilities and Good Laboratory Practice Recognition Program inspectors.

Background

On September 20, 2021, the OECD released an Advisory Document on GLP Data Integrity (No. 22).

The OECD Principles on GLP have not been revised since 1997, however the OECD Working Party on GLP continues to issue consensus, guidance, advisory, and position papers to facilitate the understanding and interpretation of the requirements as the working environment and tools used to collect data continue to evolve.

The present advisory document focuses on data integrity related to electronic data capture systems.

Although listed as an Advisory Document, the expectation is that GLP facilities within SCC’s GLP monitoring program will implement concepts/practices described within the document to the best of their ability.  The document is meant to help facilities implement processes that will provide confidence in the quality and the integrity of the data being generated, and to aid in the reconstruction of activities performed in the conduct of pre-clinical safety studies. 

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.