general detail of good lab practices...

1. GOOD LABORATORY PRACTICES
PRESENTED BY- REENA TOMER
Ph.D Scolar of panjab university

2. GOOD LABORATORY PRACTICES
Acc. To OECD principles, GLP is “a quality system concerned
with the organisational process and the conditions under which
non-clinical health and environmental safety studies are:
• Planned
•Performed
•Monitored
•Recorded
• Archived and Reported
The purpose is not to assess the intrinsic scientific value of a
study

3. In the early 1970s, the FDA
investigated a number of cases of
poor practice in toxicology
laboratories throughout the USA
The FDA decided to perform
an in-depth investigation in 40
toxicology laboratories.
FDA discovered fraud cases during investigation.
•Inadequate characterization of test items and test systems
• Inadequate resources
• Equipments were not properly calibrated.
•Reports were not sufficiently verified, inaccurate account of
study or raw data
• Inadequate archives and retrieval processes
How GLP was introduced?

4. Example
• In Industrial Bio Test lab, it was discovered that mice that they
had used to test cosmetics such as lotion and deodorants had
developed cancer and died
• threw the dead mice and covered results deeming the products
good for human consumption.
•Those involved in production, distribution and sales for the lab
eventually served jail time.

5. Resources: Organization, personnel, facilities and equipment
Characterization: test items and test systems
Rules: Study plan and Standard operating procedures
(SOP).
Results: Raw data, final report and archives
Quality Assurance: Audit/Inspection, Training , Advice
FUNDAMENTAL POINTS OF GLP

6. 1. Resources
Management and personnel
• Management must take overall responsibility for both
the conduct and interpretation of the study, including
all scientific and organizational aspects
• GLP also stresses that there should be sufficient staff to
perform the tasks required. The qualifications and the
training of staff must also be defined and documented.
Facilities and equipment
• The regulations emphasize the need for sufficient
facilities and equipment to perform the studies.
• All equipment must be in working order. To ensure this,
a strict programme of qualification, calibration and
maintenance must be adopted

7. 2. Characterization
We should have prior and proper knowledge
about the test item (pharmaceutical item)
the test system (often an animal or plant) to
which the test item is to be administered

8. Protocols and written procedures
•The institute’s rules for organizing and conducting GLP
studies must be defined in documents approved by
management.
•Rules defining who does what, how, when and
where, are called PRESCRIPTIVE documents.
• the protocol (or study plan) which describes how the study
is designed and how it is to be conducted, including the
expected timeframe of the study;
• the standard operating procedures (SOP) which provide
detailed instructions about how to actually perform each
technical procedure, and how to ensure sound organization
of the study, its environment and data.
3. Rules

9. Raw data
All studies generate raw data. These are the outcome of research and
form the basis for establishing scientific interpretations and arriving at
conclusions. The raw data must also reflect the procedures and
conditions of the study.
Final Report
The study report contains the detailed information that how the study
was performed,
 incorporate the study results and also include the scientific
interpretation of the data.
The report is provided to regulatory authorities as part of the
submission for registration and marketing approval.
Archives
Storage of records must ensure safekeeping for many years and allow
for prompt retrieval.
4. Results

10. 1Quality assurance personnel
•Quality assurance (QA), as defined by GLP, is a team of persons charged with
assuring management that GLP compliance has been attained within the
laboratory.
•QA must be independent from scientists involved in the operational aspects
of the study being performed.
•QA functions as a witness to the whole non-clinical research process.
2.Study plan contains the information-verification
•3.Conduct inspections
Study-based inspections
Facility-based inspections
Process-based inspections.
4.Records of such inspections should be retained
5. Quality
Assurance

11. GLP
 promotes the quality and
validity
of the test data.
a tool for management of
laboratory studies.
PURPOSE OF GLP

12. To help scientists obtain results
that are:
• Reliable.
• Repeatable.
• Auditable.
• Recognized by scientists worldwide.
MISSION OF GLP

13. BENEFITS OF GLP
•Reduce the number of false negatives.
(A false negative means a set of results that falsely reports that
a test item is not toxic when in reality it is toxic.)
•Assures that the data are a true reflection of their results
obtained from studies
•Promotes international recognition of study data.
•Limiting waste of resources
•Ensuring high quality of study data.
•Validity of test data.

15. General Laboratory Rules
• Each person in the lab should maintain a hardbound
laboratory notebook with continuously numbered pages as a
permanent record of his work and ideas
• Do not crowd the entries.
• Do not delete, over write or erase, instead cross out
• Do not remove pages from notebook

16. Lab should be cleaned properly.
Adequate space.
Ventilation.
Hygiene.
Periodic fumigation.
All chemicals should be labeled.
Switch off the power while leaving.
Remove slippers before entering
lab .

17. • The work area should be cleaned and
maintained in a sanitary condition.
• Surfaces or equipment where work
with biological materials is conducted
should be routinely decontaminated.
• Laboratories must have a sink for hand
washing

18. All manipulations of
infectious materials
within the laboratory
must be conducted
in the biological
safety cabinet.
BIOSAFETY CABINETS

19. Reagents used should be specified in the standard
operating procedure.
Purchasing and testing should be handled by a quality
assurance program.
Reagents and solutions should be labeled
outdated reagents and solutions shall not be used
Expiration date
Chemicals and Reagents
handling

20. • Know the hazards of each chemical before
using.
• Never use Flammable chemicals (diethyl
ether, acetone, triethylamine) in lab that has
an open flame anywhere in the room.
• Be careful not to spill any flammable
solvent on a heating mantle or hot plate.
Always clean up spills immediately.
• Corrosives like hydrochloric acid,
sulphuric acid should be handled with great
care so as not to spill them or inhale their
vapors and wear the protective gear.

21. Smoking, drinking, eating and the application
of cosmetics is forbidden in areas where
hazardous chemicals are used or stored.
Inspect equipment or apparatus for damage
before adding a hazardous chemical. Do not
use damaged equipment.
Never use mouth suction to fill a pipette. Use a
pipette bulb or other pipette-filling device.

22. Equipment handling
• Maintenance and regular inspection of laboratory equipment
are essential parts of this activity. Many of the accidents that
occur in the laboratory can be attributed to improper use or
maintenance of laboratory equipment
• Equipment shall be adequately inspected, cleaned and
maintained
• Scales & balances should be calibrated at regular intervals
(usually ranging from 1-12 months).

23. Glassware cleaning
Cleaning agents
- detergent solution
- chromic acid
- distilled water
• A brief soaking in warm detergent is usually sufficient to
remove the grease and dirt responsible for causing the
water breaks where detergent is not effective, rinse
glassware with concentrated acids.
• Use detergents or conc. HCl for cleaning hard rubber and
plastic bottles.
• After the glassware and bottles have been cleaned, rinse
thoroughly with reagent water.

24. STERILIZATION
• Complete destruction of the pathogenic organism.
• Autoclaving is the sterilization method commonly
used in research laboratories and hospitals.
• It involves heating in a chamber with saturated steam
under heavy pressure so that the chamber temperature
rises to at least 121˚C for a minimum of 15 minutes.
• All material being autoclaved must be in contact with
steam and heat for complete sterilization.
• Dry heat may also be used, though it is less effective
and takes longer durations and very high temperatures.

25. WEIGHING
• Fundamental requirement for all analyses
• Accuracy of balances
• Care in operation
- protection from corrosion
- cleaning after every use
- vibration free table
• When using digital weighing balance, switch off
the fans.
• In case of weighing volatile or corrosive
substances, take aluminum foil or butter paper.

26. PERSONAL PROTECTION

27. Face protection
• Face protection is a safety device such as a face
mask and face shield to protect the face from injury
or exposure to biological agents.

28. Fire extinguishers,
Fire blankets,
Fire alarms,
First aid kit,
Eye washes and
showers.
Fire prevention and
fire protection

29. Storage of infectious material
Potentially infectious materials must be placed
in a durable, leak proof container during
• collection
• handling,
• processing
• storage
• transport.

30. Animal handling
• Housing
- Sufficient, hygenic and ventilated space.
- Cleaning and sanitation of cages, Racks and
accessory equipment at appropriate intervals
• Feeding
-Feed and water shall be analyzed periodically to
ensure that contaminants known to be capable of
interfering with study.
• Waste disposal
-Facilities shall exist for the collection and disposal
of all animal waste and refuse

31. Waste disposal
 Immediate treatment and disposal are ideal procedures
to be followed for disposal of biomedical waste.
 Untreated biomedical waste however, can be stored for
not more than 48 hrs.
 If for some reason it becomes necessary to store the
waste beyond such period, permission from the local state
authority must be taken and it must be ensured that it does
not adversely affect human health and the environment.

32. SEGREGATION OF WASTE
RED BAG OR CONTANIER
Plastic waste
IV Sets, Tubings
Blood & Urine bags
Syringes
No Sharps
INFECTIOUS WASTE
Soiled bandages
Dressings, Cotton Swabs
Sanitary Pads
No plastics
YELLOW BAG OR CONTAINER

33. Importance of Recording of Experimental Data
• Essential for protecting one’s intellectual
property.
• Determining ownership of ideas.
• Validation of results to support grants and
manuscripts.
• Allow others to reproduce one’s work.

34. •Guidelines for good clinical
laboratory practices (GCLP) by
ICMR, 2008.
•Research methodology by
N.Gurumani
•The National Academies: Prudent
Practices in the Laboratory:
Handling and Management of
Chemical Hazards: Updated
Version, 2011
•http://www.who.int/tdr/publicat
ions/documents/glp-trainer.pdf
References

35. THANK
YOU….
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