OECD Advisory Document on Quality Assurance and position paper on quality improvement tools
Action required
Note the updated Organisation for Economic Co-operation and Development (OECD) Advisory Document on Quality Assurance and Good Laboratory Practices (GLP), and the new position paper on quality improvement tools.
Affected customers
GLP recognized and applicant facilities, and Good Laboratory Practice Recognition Program inspectors.
Background
While OECD Principles on GLP have remained the same since 1997, the OECD Working Party on GLP periodically issues 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 OECD released two publications on July 18th, 2022:
- an updated version of the Advisory Document: Quality Assurance and GLP
- a new position paper on quality improvement tools and GLP
The updated Advisory Document on Quality Assurance and GLP integrates the risk-based approach to manage GLP quality assurance (QA) programs and concepts listed on the frequently asked questions page of the OECD website.
Although listed as an advisory document, GLP facilities within SCC’s GLP monitoring program are expected to implement the concepts and practices described to the best of their ability. The document is intended to help facilities implement processes that provide confidence in the quality and integrity of the data generated, and to aid in the reconstruction of activities performed in pre-clinical safety studies.
The position paper on quality improvement tools in GLP provides examples of processes/systems that can be used by GLP facilities for ongoing quality monitoring and improvement.
Position papers provide advice on a specific topic, when the topic is related to GLP but not directly linked to the implementation of the GLP Principles. Compliance/implementation is voluntary.
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.