Good Laboratory Practices

Which of the following does NOT define what GLP is?

• set of principles that provides a framework for laboratory studies/activities

• applies to non-clinical studies, normally about chemical analysis

• defines the same standards as that of laboratory safety

• standard that ensures all data reported are true, traceable and internationally acceptable

Which of the following is NOT a requirement of a study plan?

• Test and control item description

• Test system

• Experimental Design

• Contracts

Why do we need to establish standard operation procedures (OPM & WIM)? (choose 3)

• just to satisfy the requirement

• Can serve as a training manual for new employees

• To ensure all tests are repeatable with less test-to-test variability

• to have a commitment to quality

Which of the following is NOT a factor to consider in item sampling?

• sampling must be based from defined sampling method

• sample must be able to maintain its integrity throughout its transport

• whichever's available

• samples must have proper identification and are recorded accordingly

Which of the following are NOT examples of an analytical method?

• Standard methods from ISO, ASTM, AOAC, USP

• In-house methods without method validation

• Modified standard methods based on specifications

• In-house methods with conducted method validation

Which of the following is NOT a requirement in method validation?

• Laboratory must register method validation to AOAC,ISO, USP and/or ASTM

• Laboratory must show that it can deliver consistent data within known limits

• Laboratory must test itself against agreed reference points

• Laboratory must conduct proficiency training to test accuracy with standard

Which of the following is an acceptable practice in data recording?

• using ditto marks ( " ) in the raw data

• Back dating records

• including an explanation why a data was not used

• Use if pencil and heat sensitive inks in recording raw data

Which of the following key personnel performs the study/testing?

• Archivist/ Document Controller

• Study Personnel/ Analysts

• Study Director/ Managers

• Admin officers

Which of the following is NOT a factor in considering the necessary equipment for the study?

• aesthetic design

• suitability

• working conditions

• alarms, preventive and curative maintenance

Which of the following is NOT a type of audit for GLP

• Study-based audit

• Process-based audit

• Facility-based audit

• Emotion-based audit