GLP 2 Flashcards
A PIVOTAL DOCUMENT
Study plan or protocol
The study plan or protocol is used by and for
Study director to COMMUNICATE planned study
Study plan or protocol must be APPROVED BY
Study director
A WRITTEN document of PROCEDURES
ACTIONS to be taken in response to ROUTINE FAILURE
SOPs
What facility should have an SOP and it’s APPROVED by
Testing facility
Management
Where should SOPs be available
Test and reference items
Apparatus
Materials and reagents
Record keeping
Reporting
Storage and retrieval
Test systems
QA procedures
SOPs should have ROUTINE
Inspection
Cleaning
Maintenance
Testing
Calibration
Any DEVIATION from the SOP should be AUTHORIZED by and?
Study director
Documented
SOPs for reagents and solutions
Reagents used should be in SOPs
Label reagents and solutions
Not use deteriorated or outdated
Store under AMBIENT temperature
SOP animal care
Animals should be free of any disease- if contacted: ISOLATED
Documented and retained
Different species in different rooms
Equipment should be cleaned and sanitized
Records describing WHAT HAPPENED
Descriptive documented
Data recording forms
WHAT was done
HOW it was done
WHEN the work was performed
WHO performed the work
It needs to be DOUBLE CHECKED
Results
What color of ink is used for the ORIGINAL copy of the results
Blue
It is the responsibility of the STUDY DIRECTOR
Study report
