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GLP Definitions
Principles of GLP
General
Multisite and GCLP
21CFRPart11
100
The driving document of a study that clearly indicates the objectives and all methods used for a conduct of a study
What is a protocol
100
Before use, these should be adequately inspected, cleaned and maintained, there should be an SOP outlining its use, and all records of calibration maintained.
What is equipment?
100
A place where the data is sent after the study is finalized for the timelines required in the protocol. Must be secure and limited access
What are the archives
100
A set of guidelines that outline the process for the analysis of clinical samples following the principles of GLP
What is GCLP? (Good Clinical Laboratory Practices)
100
This regulation apples to computer system security and validation as its key focus
What is 21CFRpart11
200
For a non-clinical laboratory study, the scientist with appropriate education and experience that represents the single point of control for the study
Who is the Study Director?
200
an independant group which is responsible for monitoring each study to assure Management that it follows the regulations.
Who is QA
200
The person who performed that activity
Who should do a correction to an original entry?
200
The driving document for a test site that outlines the responsibilities, and procedures to follow for a phase of a preclinical protocol
What is a workplan?
200
a system where the electronic record must be saved and authenticated manually (by hand on hardcopy)
What is a hybrid system (excel or word) for example
300
Procedures written that allow you to conduct an activity in a standardized way. A must have for all activities and equipment
What are SOPs?
300
To avoid cross contamination (mixups between studies, seperate waste area, archives etc...)
Why should there be adequate laboratory space and seperation of activities?
300
The study director
Who is responsible to make sure that all experimental data is accurately recorded and verified?
300
The person identified as responsible for a specific phase of a GLP multisite study
Who is a PI (Principal Investigator)
300
A measure that will protect unauthorized access into an electronic data system and should never be shared
What is a password?
400
any food additive, drug, biological product that is dosed to an animal for the purposes of a preclinical study evaluation
What is a Test Article
400
Must be signed by the study director before any data is collected in a clinical study
What is a protocol?
400
This role will sign the final report and is responsible to make sure that all of the GLP regulations were followed during the study
Who is the study director
400
In a multisite study there must be effective communication with this person to assure oversite. This person must be advised of all deviations, QA findings, and issues that may have arose during the study conduct by the PI.
Who is the Study Director?
400
A computer entry that will detail who, when, what and the reason for a change in electronic data
What is an audit trail?
500
Any laboratory worksheets, records, memo, notes or exact copies therof that are the result of original observations and are necessary for the reconstruction of a study
What is Raw Data
500
Documents that show that the personnel have the adequate experience and education to perform their tasks in a GLP study.
What are training records or files?
500
The person or persons who is responsible to assign a study director, assure there is a QAU, and adequate resources to perform a GLP study
Who is Management?
500
These facilities or services should not be used during a GLP study unless they have been qualified and approved.
What is a subcontractor?
500
The process of testing a system before it is placed into use, may include IQ, OQ, PQ and other deliverables
What is computer system validation?