Quality Assurance in GLP-2 Quiz

What is stressed as the importance of good laboratory practice?

• Organization, personnel, and standard operating procedures

• Resources, rules, and documentation

• Test items, final report, and archives

• Facilities, equipment, and protocols

What should the laboratory management's quality policy statement include?

• Information on initial and in-service training of staff

• The structure of the laboratory organizational chart

• A commitment to establishing a quality management system

• A policy for handling of OOS results

What is the function of the laboratory registry?

• Ensuring the traceability of the sample from receipt to completion of the analytical test report

• Maintaining an up-to-date collection of all specifications

• Establishing, implementing, and maintaining a quality management system

• Receiving, distributing, and supervising the consignment of the samples

What should the quality manual of the laboratory contain as a minimum?

• A policy for implementing and verifying corrective and preventive actions, a policy for dealing with complaints, and a policy for performing management reviews

• A policy for selecting, establishing, and approving analytical procedures, a policy for handling of OOS results, and a policy for the employment of appropriate reference substances and materials

• References to specific procedures for each test, information on the appropriate qualifications, and a policy for internal and external audit

• A quality policy statement, the structure of the laboratory, and the operational and functional activities pertaining to quality

What should the laboratory or organization management establish, implement, and maintain?

• A commitment to good professional practice and quality of testing, calibration, validation, and verification

• A policy for participation in proficiency testing schemes and collaborative trials

• A quality management system appropriate to the scope of its activities

• A policy for selecting service providers and suppliers