Updated OECD Documents

Bulletin date:
Bulletin number:
2022-22

Action required

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

 

Affected customers

SCC GLP-recognized and applicant facilities, and inspectors.

 

Background

The OECD published the following: 

  • a discussion related test items, reference items and samples/specimens (clause 6.2.5) on their frequently asked questions (FAQ) webpage published on October 11, 2022.
    • It presents three main points: 1. The typical situation, 2. How to apply the clause to field trials, and 3. To clarify that the clause that the clause must be satisfied even if not directly stipulated in the OECD test guidelines. 
    • The clause states that: If the test item is administered or applied in a vehicle, the homogeneity, concentration and stability of the test item in that vehicle should be determined. For test items used in field studies (e.g., tank mixes), these may be determined through separate laboratory experiments.
       
  • a re-issued version of Document #23: Advisory Document on Quality Assurance and GLP (PDF) in which  some section numbers listed in one of the footnotes are updated. The main content in the document remains unchanged. It was published on November 4, 2022.
     
  • an updated version of Document #17: Advisory Document on the Application of GLP Principles to Computerised Systems (PDF) in which section 1.6, paragraph 34 is updated to include a footnote describing that GLP monitoring authorities may inspect hosted services. It was published on November 9, 2022.
     

While OECD Principles on GLP have remained the same since 1997, the OECD Working Party on GLP periodically issues, revises and updates frequently asked questions, 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.

 

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.