GLP (Good Laboratory Practice) is a quality system for non-clinical health and environmental safety studies. It aims to ensure quality, uniformity, consistency, reproducibility, traceability, reliability and integrity of test data. Key aspects of GLP include standardized procedures for conducting studies, recording and reporting data, and archiving records and materials. GLP was established after fraud was discovered in toxicology lab data submitted to regulators. Adherence to GLP helps ensure the reliability and integrity of non-clinical safety studies.

1. GLP
A quality system concerned with the organizational
process and conditions under which non-clinical health
and environmental safety studies are
- Planned
- Performed
- Monitored
- Recorded
- Archived
- Reported

2. History of GLP
• Introduced in New Zealand and Denmark in 1972
• The US in 1978 after Industrial Bio Test Labs (IBT) scandal
• IBT falsely claimed thousands of safety tests
• Cases of fraud generated by toxicology labs in data submitted to the FDA
• FDA investigated 40 toxicology labs & discovered fraudulent activities
• Tests which the investigators could not understand & correlate

3. Spread of GLP
• In 1979, the Environmental Protection Agency (EPA) encountered similar
problems and issued its own GLP regulations
• In 1981, the Organization for Economic Co-operation and Development
(OECD) produced GLP principles which became international standard
• In 1987, the European Council adopted GLP principles
• In 2004, the European Parliament harmonised laws regulating GLP
• In 2005, Ecolable established ecological criteria for sanitary facilities

4. Need for GLP
• Examples of some of these poor lab practices found were
- Equipment not calibrated to standard form
- Incorrect/inaccurate accounts of the actual lab study
- Inadequate test systems
- Missing steps of the analysis
- Results not validated
- Records not maintained properly
- Specimens/samples not archived for retrieval

5. Objective of GLP
• Quality
• Uniformity
• Consistency
• Reproducibility
• Traceability
• Reliability
• Integrity

6. Parameters of GLP
1. Organization and Personnel Management
2. Quality assurance program
3. Lab Facilities
4. Equipment & materials
5. Systems & protocols
6. Test & reference items
7. SOP’s & work instructions
8. Performance & conduct
9. Reporting of results
10. Storage & archival

7. GLP
• Test systems - physical/chemical, biological
• Test and reference items
• Standard operating procedures
• Performance – plan & conduct
• Reporting of results
• Archival - storage of records and reports

8. Klimisch Score
• Ranks reliability of toxicity studies for use by risk assessors
• Published in 1997, by BASF
• Widely used in chemical risk assessments
• Studies performed according to GLP are assigned the top
rank of 1
• Lower ranks typically require a new study to be performed
• When no GLP study is available for a particular endpoint, a
study with a rank of 2 is usually accepted

9. Responsibilities
• Knowledge of the GLP principles
• Access to the study plan and appropriate SOP’s
• Comply with the instructions of the SOP’s
• Record & retain raw data
• Ensure quality & uniformity of work
• Exercise health precautions to minimize risk
• Ensure the integrity of the study

10. Inspections
• Access to the updated study plans and SOP’s
• Documented verification of the compliance of study plan to
the GLP principles
– Study-based inspections
– Facility-based inspections
– Process-based inspections
• Final reports for accurate and full description
• Report the inspection results to the management

11. Facilities
• Suitable size, construction and location
• Adequate degree of separation of the different activities
• Isolation of test systems and individual projects
• Protection from biological hazards
• Suitable rooms for the diagnosis, treatment and control of diseases
• Storage rooms for record keeping

12. Materials
• Apparatus of appropriate design and adequate capacity
• Documented Inspection, cleaning, maintenance and calibration
• Apparatus and materials not to interfere with the test systems
• Chemicals, reagent and solutions should be properly labelled
• Indicate identity, expiry and specific storage instructions

13. Test Systems
• Physical and chemical test
• Biological test systems
• Source & date of receipt
• Conditions at arrival
• Proper identification
• Adequate marking when removed from container
• Cleaning and sanitization of containers
• Pest control agents to be documented

14. Reference Items
• Receipt, handling, sampling and storage
• Characterization
• Stability of test and reference items
• Stability of the test item in its vehicle
• Experiments to determine stability in tank mixers
• Samples for analytical purposes for each batch

15. SOP
• Written procedures for a laboratories program
• Define how to carry out protocol- specified activities
• Often written in a chronological listing of action steps
• Written to explain how the procedures are suppose to work
• Routine inspection, cleaning, maintenance and calibration
• Actions to be taken in response to equipment failure
• Keeping records, reporting, storage, mixing, and retrieval of data
• Definition of raw data
• Analytical methods

16. Performance of the Study
• Prepare the Study plan
• Specify content of the study plan
• Identify aspects of the study
• Maintain records
• Adhere to timelines
• Reference to test methods
• Information concerning the sponsor and facility
• Conduct of the study

17. Reporting of Results
• Information on sponsor and test facility
• Experimental starting and completion dates
• Quality Assurance Program Statement
• Description of materials and test methods
• Results – summary & descriptive data
• Storage (samples, reference items, raw data, final reports) etc

18. Records
• Retention of Records and Materials
• The study plan, raw data, samples
• Inspection data and master schedules
• SOPs & work instructions
• Maintenance and calibration data
• Disposal/expiry -reason to be justified and documented
• Index of materials retained

19. Work Place
• Area should be free from smoke, smell, dust
• Ensure good ventilation, proper illumination and prefer natural light
• Air conditioned the lab with humidity control
• Enough space for measuring and testing instrument.
• Proper arrangement of testing
• Ensure safety points including proper earthing as well as fire safety
• Avoid uncleanable spots in floors, walls, ceiling
• Establish proper storage of incoming samples as well as tested material
• Allocate place for sample collection, packing and disposal

20. GLP Principles
• Keep the things at its location after use
• Store heavy things at bottom & if possible on Trollies
• Give name of location to everything
• Follow “Everything has the place & Everything at its place”
• Prepare location list & display it
• Put ladders for things stored on top
• Identify everything with its name/ purpose
• Follow “FIFO” to prevent old accumulation for chemicals

21. GLP Benefits
• Provides better analysis of data
• Details testing and measurement
• Improves maintenance of instruments
• Preserves test records
• Enhances image of company as a quality producer

22. CMP
• Compliance Monitoring Program
• Responsibilities for monitoring GLP
• Compliance of test facilities
• Inspections of GLP test facilities
• Audits of GLP studies
• Determine compliance with the OECD Principles