Good Laboratory Practices
Good Laboratory Practices
Good Laboratory Practices
Merlin Dinesh
1st Year CREM
FAHS, CARE
GOOD LABORATORY PRACTICE (GLP)
Reporting of
Facilities
study results
PRINCIPLES
Apparatus,
Performance
Materials and
of the study
reagents
Each test facility management should ensure that these GLP Principles are complied with,
in its test facility.
Test facility personnel should ensure
• sufficient number of qualified personnel, appropriate facilities, equipment, and materials
are available for the timely and proper conduct of the study.
• personnel clearly understand the functions they are to perform.
• documented approval of the study plan by the Study Director.
• the maintenance of a record of the qualifications, training, experience and
job description for each professional and technical individual.
• the maintenance of historical file of all SOPs.
2. Quality Assurance Program
• Study Plan: written plan approved by SD and verified for GLP compliance.
• Information Concerning the Sponsor and the Test Facility: Name and address of SD,
PI, TFM and sponsor
• Dates: date of approval by SD, TFM as well as sponsor
• Test Methods: Reference to the OECD Test Guideline
• Issues : method of administration, dose level, types and frequency of analysis.
• Records: all sort of records
9. Reporting of study results
Identification of the study, Test item and the reference item: descriptive title and
characterisation of test and reference item
Information Concerning the Sponsor and the Test Facility: Name and address of
SD, PI, TFM, PI and sponsor
Date: date of approval by SD, TFM as well as sponsor