GLP-Training ppt

1. Procedures and Good
Laboratory Practices (GLPs)

2. Good Laboratory Practices (GLP)
◼ GLP embodies a set of principles that
provides a framework within which
laboratory studies are planned
performed, monitored, reported and
archived.
◼ Applies to non-clinical studies.
◼ GLPs must not be confused with
standards of laboratory safety like
wearing lab coats etc.

3. WHY WAS GLP CREATED?
1. Poor laboratory practice.
2. Equipment not been calibrated to standard form ,therefore
giving wrong measurements.
3. Incorrect/inaccurate accounts of the actual lab study.
4. Inadequate test systems

4. History of GLP
• Formal Regulation of FDA.
• 1972: First introduced in New Zealand and Denmark
• 1978: Introduced in US in response to ‘Industrial Bio Test Labs’
scandal.
• 1981: an organization named OECD (organization for economic
co-operation and development) produced GLP principles that are
international standard.
• International Organization for Standardization (ISO).

5. Objectives of GLP
• GLP makes sure that the data submitted are a true
reflection of the results that are obtained during the
study.
• GLP also makes sure that data is traceable.
• Promotes international acceptance of tests.

6. To certify that every step of the analysis is
VALID
Goal

7. Mission of GLP
• Test systems
• Standard operating procedures (SOP)
• Personnel and test facility organization
• Archiving of records and materials
• Apparatus, material and reagent facilities
• Quality assurance programs
• Performance of the study
• Reporting of study results

8. Mission of GLP

9. GLP Organization and Conditions
Study Investigator
Quality assurance unit
Personnel
Standard operating procedures
Control and test articles
Equipment

10. For each study to be
performed, the facility
management must appoint a
study director – the
individual responsible for
the overall conduct of
the study.
Study Director

11. Quality Assurance Unit
Must be designated to audit the laboratory studies and the
accompanying data.
It may be a separate department or an individual person,
either full- or part time, indeed any person other than the
study director.
QAU is also responsible for preparing a GLP inspection and
for supplying the data to the FDA or other control agencies.
The QAU is designated by the testing facility management.

12. Must be qualified through education, training and/or
experience to follow directions and perform test
procedures properly.
Personnel

13. Standard Operating Procedures
(SOPs)
All laboratory activities must be performed
in accordance with
• correctly written and
• properly filed,
• management-approved standard
operating procedures (SOPs).
• These must be readily available to the
personnel concerned.
• They should cover policies,
administration, technical operation,
equipment operation and analytical
methods

14. Cont’d…
• Written procedures for a laboratories program.
• They define how to carry out protocol-specified
activities.
• Most often written in a chronological listing of action
steps.
• They are written to explain how the procedures are
suppose to work

15. Copies of SOPs for equipment should be located close to the instruments and must
be easily accessible by operators.

16. Must be identified and characterized by strength,
purity, and stability.
Reagents and solutions must be labeled with
information on origin, identity, concentration, storage
conditions, and expiration date.
Control and test articles

17. Equipment
Instruments must be designed to meet analytical
requirements and regularly maintained and calibrated
and copies must be kept on these procedures.

18. How to conduct a GLP study
• A protocol must be in place for each study.
• The protocol should be written before the start of the
study.
• Scientifically justified changes can be made, if the
changes are documented and authorized by the study
director.

19. Frequency of Inspections
• This varies from country to country.
• In the US, the FDA has two different types of
inspections:
– The routine inspection constitutes a periodic determination
of the facility’s compliance with the regulations. The
toxicological facilities and animal handling areas may be
inspected annually, but frequently the laboratory itself is not
inspected. A data audit may be done.
– Cause inspections are conducted less frequently. The
assignment of this inspection is sometimes initiated by
routine inspections when serious non-compliance with GLP
regulations is found. Laboratories are not notified
beforehand.

21. Good Laboratory Safety
Practices

22. • When performing potentially hazardous/dangerous
operations always:
– Make sure someone is in the laboratory with you
– Notify someone that you are in the lab and what time
you will check with them when you complete your
work.
– Check-in with that person if you exceed your time
estimate or if you leave.
Work as a Team

23. A Clean Lab is a Happy Lab

24. A Cluttered Lab is a Dangerous Lab!
Keep your lab clean!

25. Housekeeping
The Results of Poor housekeeping:
• Accidents
– Messy counter tops are a good source of spills.
– Poorly maintained equipment or apparatus can
break spilling its contents, damage other
equipment or flying debris can cause injury.
– Containers and equipment on the floor can cause
hazard.

26. Housekeeping
The Results of Poor
housekeeping:
• Costs you money
– Overstocking or reordering
of chemicals due to
uncontrolled or unmanaged
inventory.
– Replacing spilled chemicals
or damaged equipment.

27. Housekeeping
The Results of Poor housekeeping:
• Contaminates your research
– Poorly washed containers or equipment
can lead to cross contamination.
– Poorly labeled storage
containers can lead to
the use of a wrong
reagent.

28. Housekeeping
Poor housekeeping:
• Causes accidents:
• Costs you money
• Contaminates your research
• Sets up bad habits for students
entering a more regulated
industrial setting.
• Gets more attention from
inspectors.

29. Don’t Block Access to Electrical Panels, Safety Showers
and Eye Wash Stations

30. Don’t block doors or Fire Extinguishers

31. Old Equipment Can Be Dangerous
Rusty water-bath with exposed wires
Maintain your
Equipment!

32. Improper Chemical Storage
• Ether was stored in
domestic style
refrigerator. Either
the thermostat or the
interior light was the
ignition source that
caused the explosion.
• Flammables have to be
stored in a Flammables
or Explosion proof
fridge.

33. Lack of Attention to Details
Heater/stir plate
being used to stir
only accidentally
was also turned on
as hot plate also!

34. Incomplete reaction placed in
refrigerator
Reaction container was placed into the refrigerator
before the reaction had been completely quenched.
The bottle over pressurized and exploded.

35. Do Not Store Consumables with
Chemicals!

36. Proper Equipment Usage
• There needs to be a written Standard Operating
Procedure for all equipment.
• Everyone should be properly trained before using any
equipment.
• Improperly used or maintained equipment can be
dangerous to your health or can result in expensive
damages.
• Fires are common result with inappropriate equipment
usage.

37. Centrifuges- An Example of Improper Usage
and Maintenance

38. Hazards
• Mechanical failure of rotating parts (often violent).
• Contact with rotating parts.
• Sample leaks causing aerosols, stress corrosion,
contamination.
• Sample imbalance causing machine movement / walking (or
stress failure of component parts).
• Fire or explosion.
• Health (contact with contaminated components / vapors).

39. Rotor Failure

40. Rotor Failure

41. Rotor Failure

42. Dancing Centrifuge
This can be caused by an improperly balanced rotor.

43. Remember Good Practices
• Never work alone.
• Commit to good housekeeping
• Do not block access to doors, electrical or emergency
equipment
• Store chemicals and wastes properly
• Maintain equipment

44. The End