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WorksheetsGood Laboratory Practices
Total questions: 15
Worksheet time: 8mins
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
Which of the following is NOT a requirement for analytical equipment in the laboratory?
Equipment Record and Log
Calibration and Service Schedule
Equipment Labels and Specifications
Equipment Photo Display
Why should we adopt the GLP? (choose 3)
this provides a systematized process for the whole study
this is to ensure the safety of all personnel in the lab
this ensures high quality and comparable results
ensured that obtained results from testing/study are reliable, repeatable and audible
Complete the chain of custody for all samples received:
Sampling, Receiving, Endorsement, _______, Testing, Disposal
Looking at Sample
Return of Sample
Clapping at Sample
Storage of Sample
Which of the following is NOT a requirement for a sample storage area?
With controlled access
With proper and monitored storage conditions
must have an air freshener to avoid off smell
must prevent sample deterioration and contamination
Which of the following is NOT a factor in formulating an in-house method?
Parameters for testing
Technical Requirements
Uncertainties
Analyst to do the procedure
Procedure
