ISO 17025 Personnel Competence and Training Checklist for Pharmaceutical Labs

A compliant training program should include initial training for new staff, ongoing training for existing staff, method-specific training, instrument operation training, quality management system training, and safety training. It should also cover ethical considerations and data integrity principles specific to pharmaceutical testing.

ISO 17025 does not specify a fixed frequency, but it's generally recommended to conduct competency assessments annually. Additionally, assessments should be performed after significant changes in methods or equipment, or when performance issues are identified. New employees should be assessed more frequently during their initial period.

Competence can be evaluated through various methods including direct observation of test performance, review of records, proficiency testing participation, blind sample analysis, written or oral examinations, and review of reported results. The chosen methods should be appropriate for the specific tasks and responsibilities of each role.

The checklist includes items to verify that the laboratory has a system for identifying relevant developments in pharmaceutical testing and analytical techniques. It covers aspects such as access to scientific literature, participation in conferences or workshops, internal knowledge sharing sessions, and incorporation of new information into training programs.

The laboratory should maintain comprehensive records including job descriptions, CVs, training logs, competency assessment results, continuing education activities, and authorizations to perform specific tests. These records should be regularly updated and readily accessible for internal quality reviews and external audits.