GXPs
Its the law (## LLL ##)
What is 21 CFR 58?
Personnel must have the appropriate ___, ___, and ___ to perform their assigned responsibilities.
What are education, training and experience?
Suitable for intended use, calibrated and periodically recalibrated per SOP, used within calibration and maintenance due dates
What is [GXP] equipment?
Signatures meaning "Read and Understood by" and "Confirmed to be true by"
What are "Reviewed by" and "Verified by"?
Five letter pneumonic for documentation requirements.
What is ALCOA?
cGLPs
What is Current Good Laboratory Practices?
Records maintained to help establish the qualifications of each person who participates on a GLP study
What are CV and current Job Description?
Reagents and solutions must be labeled to indicate ...
What are Identity; Strength, titer or concentration; Storage requirements, and Expiration date?
Lab worksheets, records, memos, notes, or exact copies thereof, that are the result of original observations and activities of a nonclinical laboratory study
What is raw data?
Documentation must be _____ to the person who did the work.
What is attributable?
Regulation that governs conduct of nonclinical safety studies
What is Good Laboratory Practice (GLPs)?
Corrections require
What are single line cross-out; reason; initial and date?
Reagents and solution must be discarded ...
What is on or before the expiration date?
Not considered raw data (i.e., what does not belong): photographs, computer printouts, recorded data from automated instruments, contact info (phone/email for project colleagues)
What is contact info (phone/email for project colleagues)?
Documented at the time the work is performed.
What is contemporaneous?
Regulation applicable to pharmaceutical QC laboratory testing
What is Good Manufacturing Practice (GMPs)?
Legally binding equivalent of an individual's handwritten signature
What is electronic signature?
Reagents labeled "For Research Use Only" may be stored in the GLP lab/area (True or False)
What is False?
Data about data
What is metadata?
ALCOA
What is Attributable, Legible, Contemporaneous, Original, and Accurate
WHO Guideline applicable to testing of clinical trial samples
What are Good Clinical Laboratory Practice Guidelines (GCLPs)?
Personnel are legally responsible for actions taken under their ___ and ___.
What are Username and password?
Responsible to ensure adequate resources are available as needed
What is Testing Facility Management [Management with Executive Authority]?
Reviewed as part of the electronic data review to confirm data integrity
What is audit trail?
Daily Double: For ALCOA +, add C_______, C_________, E_______ and A________.
What are Complete, Consistent, Enduring and Available?
(Daily double)