OECD GLP Series - Critical Points in OECD GLP TICO Responsibilities
The Test Item Control Office (TICO) plays a crucial role in ensuring the quality and integrity of non-clinical laboratory studies conducted under the Organisation for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP). The TICO is responsible for the procurement, storage, handling, distribution, and documentation of test items, reference items, and samples/specimens used in GLP studies.
The TICO’s responsibilities are critical to ensuring that the test items used in GLP studies are of known quality, purity, and composition, and that they are handled and stored in a manner that preserves their integrity throughout the study.
Key Responsibilities of the TICO
Procurement of Test Items:
- Identify and select qualified suppliers of test items.
- Establish and maintain specifications for test items.
- Review and approve supplier documentation.
- Procure test items in accordance with established procedures.
Storage and Handling of Test Items:
- Receive and store test items under appropriate conditions.
- Maintain an accurate inventory of test items.
- Label and track test items to ensure traceability.
- Handle test items in a manner that preserves their integrity.
Distribution of Test Items:
- Prepare and distribute test items to study personnel in accordance with study protocols.
- Record and maintain distribution records.
- Monitor the use of test items throughout the study.
Documentation of Test Item Control Activities:
- Maintain detailed records of all test item control activities.
- Prepare and maintain SOPs for test item control.
- Ensure that test item control records are readily accessible for inspection.
Training of Personnel:
- Train personnel on test item control procedures and SOPs.
- Ensure that personnel are competent in performing test item control activities.
- Provide ongoing training to keep personnel up-to-date on test item control practices.
Critical Points in TICO Operations
Accuracy of Test Item Information:
- Ensure that test item specifications are accurate and complete.
- Verify the identity and purity of test items upon receipt.
- Maintain accurate records of test item characteristics.
Maintaining Test Item Integrity:
- Store test items under appropriate conditions to prevent degradation or contamination.
- Handle test items with care to avoid damage or loss.
- Monitor test item storage conditions and take corrective actions as needed.
Traceability of Test Items:
- Assign unique identifiers to test items.
- Maintain a chain-of-custody record for test items.
- Ensure that test items can be traced back to their source.
Compliance with SOPs and Regulations:
- Develop and implement SOPs that meet GLP requirements.
- Train personnel to follow SOPs and regulations.
- Conduct regular audits to assess SOP compliance.
Communication and Collaboration:
- Communicate effectively with study personnel regarding test item control.
- Collaborate with other TICO personnel to ensure consistent practices.
- Share information and best practices with other TICOs.
Additional Notes
- The specific responsibilities of the TICO may vary depending on the specific requirements of the GLP study.
- The TICO should have written procedures in place for all of its critical responsibilities.
- The TICO should be trained on the critical points in its responsibilities.
- The TICO should be audited periodically to ensure that it is following the critical points in its responsibilities.
The TICO plays a critical role in ensuring the integrity of GLP studies. By following the critical points in its responsibilities, the TICO can help to ensure that GLP studies are conducted in a sound and scientific manner that produces reliable and defensible data.
