CBA facility is set up as a GLP compliant facility to offer high quality analytical characterization services. The processes are devised following the OECD guidelines. CBA will soon be submitting an application for GLP certification to NGCMA.
This checklist is meant to provide a quick look at the GLP compliant processes followed at CBA.
Organization and Laboratory Personnel
Does an organizational chart exist for CBA?
Is there a training and evaluation plan for all personnel aligned to the job description?
Have personnel received health/safety training?
Is there a process to report incidents and deviations?
Are external Vendors qualified before engagement?
Quality Assurance Program
Is there a Quality Assurance Unit?
Is the Quality Assurance Unit independent from the personnel engaged in the study?
Does the Quality Assurance Unit perform audits and report the results to the Laboratory Management?
Standard Operating Procedures
Is there a current index listing of the SOPs available?
Is there a schedule for review of the SOPs?
Are the SOPs in locations where they are used?
Are there SOPs for reporting deviations and CAPAs?
Is there a change control system for SOP/methods?
Is the access control to the facility?
Is there sufficient segregation between areas marked for storage of chemicals, archiving records, equipment, and sample preparation?
Is there a system to code test samples and reference samples and prevent cross contamination?
Is there safety equipment (e.g., showers, eyewash stations) available? Is the safety equipment maintained?
Are there environmental controls within the laboratory and are the controls monitored?
Is there a power back up provision at the facility?
Are the equipment uniquely identified with a defined identification number?
Are the equipment manuals and SOPs available for ready reference?
Are there log books for each equipment that include a chronological record of use?
Equipment calibration and/or preventative maintenance schedules have been established and are being followed and documented
Is system access limited to authorized individuals only?
Are Good Documentation Practices followed?
Is raw data recorded in lab notebooks or electronically and is controlled?
Is there a SOP that outlines the content of the final report?
Is there a dedicated facility/area for the archival of records?
Is there a method of electronic data archive?
Samples/Reagents/Chemicals/ Methods Control
Is the sample receipt area maintained separate from the sample processing area?
Is there an SOP that outlines how reagents are labelled, how expiration dates are established?
Are there validated methods and acceptance criteria for each test method?
Are changes to computer systems controlled and documented?
Are records of hardware maintenance and repairs maintained?
Are computers backed up routinely to prevent loss of data? Is there a backup log?
Are there a computer validation master plan and/or SOPs?
- The OECD Principles of Good Laboratory Practice (as reviewed in 1997), No. 1, OECD series on Principles of Good Laboratory Practice and Compliance Monitoring (ENV/MC/CHEM (98)17).
- International Organization for Standardization. (2017). ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories. (NABL certification)