GLP PPT.ppt

Good Lab Practices

1. GLP IN PHARMACEUTICAL
INDUDTERY

2. SCOPE
ScopeofthisPresentationistocoverGood
LaboratoryPractice(GLP)requiredfor
PharmaceuticalProductsalsoknownas“Drug
Product”

3. DEFINATION& IMPORTANCE
TheprinciplesofGoodLaboratoryPractice
(GLP)defineasetofrulesandcriteriafora
qualitysystem concerned withthe
organizationalprocessandtheconditions
underwhichlaboratorystudiesareplanned,
performed,monitored,recorded,reportedand
archived
TheGLPplaysanimportanttoensuresafety,
qualityanduniformityofPharmaceutical
products.

4. MAIN FEATURES OF GLP
Laboratory Safety
Accuracy
Reliability
Reproducibility
Documentation
Training
Review/Check

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

7. STANDARD OPERATING PROCEDURES (SOP)
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

8. INSTRUMENTATION VALIDATION
This is a process necessary for any analytical laboratory.
Data produced by “faulty” instruments may give the
appearance of valid data.
The frequency for calibration, re-validation and testing depends
on the instrument and extent of its use in the laboratory.
Whenever an instrument’s performance is outside the “control
limits” reports must be discontinued

9. REAGENTS AND SOLUTIONS
Requirements:
Reagents and solutions shall be labeled
Deteriorated or outdated reagents and solutions shall not
be used
Include Date opened
Stored under ambient temperature
Expiration date

10. LABORATORY SAFETY
Itisveryimportanttobesafewhenworkinginalaboratory.
WearPersonalProtectiveEquipment(PPE)suchasGoggles&
Gloves
AvoidexposuretoHazardousMaterialbyplanningall
proceduresbeforestartinganylaboratorywork.

11. BEFORE LAB WORK, GET TO KNOW:
Hazards of materials
& agents and their
prescribed safety
procedures

12. ALSO GET TO KNOW:
Emergency spill
procedures, use of
adsorbents and
disinfectants
Designated escape
route and alternate
Location of fire
ext., eye wash,
shower, first aid, and
spill kits

13. WHILE WORKING IN THE LAB:
Shoes with full
coverage and good
grip soles
Restrain long hair,
loose clothing and
jewelry
Use appropriate
eye, skin, and hand
protection

14. EYE PROTECTION
Protects against risk
of flying objects or
dust particles,
splashes of
hazardous materials
or harmful rays

15. GOGGLES
Work with significant
risk of splash of
chemicals or
projectiles
Can be worn over
prescription glasses

16. HAND PROTECTION
Protects against
risk of cuts,
abrasions, burns, or
exposure to
hazardous materials.
Requires selection
of theappropriate
chemical resistant
gloves

17. WHILE WORKING IN THE LAB:
Handle volatiles in
a chemical fume
hood
Contain
bioaerosols in a
biological safety
cabinet

18. WHILE WORKING IN THE LAB:
Authorized
persons only
Identify
EVERYTHING!
No food,
beverages, tobacco
products, or
application of
cosmetics

19. BEFORE LEAVING THE LAB:
Turn off:
Gas
Water
Power supplies
Vacuum lines
Compression lines
Heating apparatus

20. TRAINING
Requirements for training of Lab. Colleagues:
Certification of Analysts
Job competency standards
Job descriptions
Continuing education programs and annual refreshers are
fundamental for GLP Compliance.

21. WHAT ARE THOSE GOOD LABORATORY PRACTICES?
CHEMICAL LABORATORY:
All analytical data generated by an Analysts must be counter check by
second analyst with full signature and date.
All the documents must carry the name of the products and batch# and
date.
Use of Blanco or other similar correction fluid must be prohibited in the
Lab.
Correction can be done by simple cross once and sign.
Testing must be done as per approved Method or SOP.
No manual correction should be done on already approved method or
SOP.
If any such method need correction, then proper procedure of such
revision must be in place.
All raw data must be available for review and check.
All the instrument must be calibrated as per procedure and frequency
defined.
Handling and storage of Reference Standard both Primary and
Secondary.

22. CONCLUSION:
The result of GLP is that the performance of a
laboratory is improved and its working effectively
controlled. This results in an improved reputation
for the laboratory (and for the institute as a whole).
In short, the message is:
-say what you do
-do what you say
-do it better
-be able to show what you have done

23. Thank You