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WorksheetsGLP Definitions
Total questions: 18
Worksheet time: 9mins
What is the definition of the term "Good Lab Practices?"
A set of recommended practices in the lab such as politeness with lab peers, PPE, and data recording.
A quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
A charter of FDA guidelines for working in the lab.
The opposite of "Bad Lab Practices"
Define "test facility management"
Managers who over see the cleanliness of labs.
The individual person who enforces PPE in the labs.
A facility where animal testing takes place.
The person who has the authority and formal responsibility for the organization and functioning of the test facility.
Define "top management"
The management that manages bottom management which is not to be confused with middle management.
The management that oversees controlled testing.
Ensures that a statement exists which identifies the individuals within a test facility who fulfill responsibilities of management.
Ensures that a hierarchy exists which identifies the individuals within a group of lab workers that manage lab practices.
Who is the "study director"
The director of studying lab reported data.
The individua responsible for the overall conduct of the clinical health study and environmental impact study.
The head of the testing facility.
The individual responsible for the overall conduct of the non-clinical health and environmental safety study.
Who is the "Principle Investigator?"
An individual who, for a multi-site study, acts on behalf of the Study Director and has defined responsibility for delegated phases of the study.
The individual responsible for all lab data and ensures accuracy.
The individual responsible for documenting and reporting lab incidences/accidents.
The head of the investigating team for lab related crimes.
What are "test facilities?"
The location at which lab techs test a product for quality.
The operational units that are necessary for conducting the non-clinical health and environmental safety study.
The location(s) at which a phase(s) of a study is conducted.
The operational units that are necessary for conducting the clinical health and environmental impact study.
What are "test sites"
The operational unit(s) that are necessary for conducting the non-clinical health and environmental safety study.
The site at which environmental safety of chemicals is tested.
The operational unit(s) that are necessary for conducting research on the impact of chemicals.
The location(s) at which a phase(s) of a study is conducted.
What is the definition of a "non-clinical health and environmental safety study?"
an experiment in which a test item is examined under natural environmental conditions to obtain data on the effects of chemicals in the environment.
an experiment in which chemicals are used in a controlled environment to document their impact on plants and wildlife.
an experiment or set of experiments in which a test item is examined under laboratory conditions or in the environment to obtain data on its properties and/or its safety, intended for submission to appropriate regulatory authorities.
an experiment in which chemicals are used on a control group and a study group to document their effects.
What is a "Study Plan?"
A document which defines the objectives and experimental design for the course of the study.
A document which defines the plans for lab documentation.
An SOP (Standard Operations Procedures) guideline.
A general recommended guideline for the lab team to follow.
What is a "deviation?"
The intentional non-compliance for PPE and lab safety rules.
The unintended departure from the study plan after the study initiation date.
The intended departure from the study plan after the study initiation date.
An incidence/accident in a lab.
What is an "amendment"
A properly corrected lab document which includes the initials, justification, and date from the individual making the correction.
An action in which a lab incident/accident report has been completed and accounted for.
The document in which prevents the government from making laws which regulate best lab practices.
An intended change to the study plan after the study initiation date.
What is "raw data?"
Data that has not been documented yet but only observed.
Cook data chicken, don't eat it raw.
All data records and documentation that has not been verified yet but observed.
All original laboratory records and documentation, or verified copies thereof, which are the result of the original observations and activities in a study.
What is a "phase of study"
A phase at which all documentation has been made and the data is studied to report lab findings.
The moment in which experiments are halted to record the findings and study the data collected.
A defined activity or set of activities in the conduct of study.
The phase at which raw data is collected and reviewed for a collected hypothesis.
What is the "critical phase"
The crucial phase of a study in which all lab members are required to work on the experiment.
A very critical phase of study in which only the top management is involved.
A very restricted part of a study, down to single, but highly important activities, on which the quality of a study is "critically" dependent.
The phase at which an experiment has deviated to the point of no return.
What is a "master schedule?"
A compilation of information to assist in the assessment of workload and for the tackling of studies at a test facility.
A detailed list of employees and what projects they are assigned to.
A copy of all lab employees/management schedules used to ensure that there is ample coverage for an experiment during the critical phase.
A scheduled of all testing site availabilities.
What is a "test item?"
An article that is used on a test subject to document the effects the items has on the test subject.
A control group that is given the "placebo" to determine the effects of a chemical/product on a test group.
The item at which is used to inject/subject test subjects to.
An article that is the subject of study.
What is a "control item?"
Any article used to provide a bases for comparison with the test item.
An article that is used to control the environment at which the experiments are taking place.
An article that is the subject of study.
An article that is used to control the test subjects reactions.
What is the "internal standard?"
The standard and set of morals for which each lab technician follows while adhering to GLP.
The standard that provides guidelines for lab PPE, cleanliness, and conduct.
A standard used to provide the basis for the calculation of concentration values from the output of the system in terms of "peak area."
A code of conduct that all lab facilities are required to adhere to.
