What does our Good Laboratory Practice standard (GLP) mean to your project?
Good Laboratory Practices (GLP) are internationally recognized guidelines designed to ensure the quality and integrity of non-clinical study data. In the US these guidelines are defined in the Code of Federal Regulations 21CFR part 58. More generally these guidelines cover the requirements for ensuring that the quality and integrity of the study data is reliable and describes how these studies are planned, conducted, monitored, recorded, reported, and archived. The requirements cover animal studies, but the rules are generally applicable more generally. At CPG, we comply with GLP in the following ways:
Control and Sample Management
- Sample Storage and Handling: We maintain physically separated sample storage.
- Documentation and Tracking: Our comprehensive sample documentation protocol includes receipt logging, tracking, inventory management, and archiving of all GLP samples to ensure error-free sample tracking and traceability.
- Laboratory Cleanliness: We enforce an effective laboratory cleanliness policy to prevent contamination.
Data Security
- Encrypted Reporting: Reports are emailed in encrypted form to ensure confidentiality
- Network Security: We monitor for network intrusions to protect your data.
- Data Backup and Archiving: All computer data is backed up offsite, and laboratory notebooks and samples are securely archived.
Accuracy and Reliability
- Standard Operating Procedures (SOPs): We have established SOPs for all laboratory equipment involved in GLP research.
- Equipment Maintenance: Regular inspections, maintenance, cleaning, and calibration ensure that all equipment is functioning correctly.
- Data Recording and Auditing: Comprehensive SOPs are in place for recording and auditing data to prevent errors.
Planning and Protocol Development
- Custom Study Protocols: We develop detailed, client-approved protocols to define study plans and activities.
- Protocol Review and Audit: Protocols are reviewed and audited before study launch.
- Collaboration: Close collaboration with client teams is essential during this phase.
Comprehensive Reporting
- Detailed Protocols: Fully descriptive protocols with signed records of any deviations.
- Methodologies and Conditions: Descriptions of procedures, statistical methodologies, and conditions that may have influenced data quality.
- Data Operations: Details of operations performed on collected data.
- Conclusions and Sign-offs: Conclusions drawn from results, with signed and dated reports from the principal scientist, independent reviewers, and quality specialist approval.
Get Started with GLP in Your Project
Contact one of the scientists at CPG to ask how GLP can be used in your project.