Quality control in ayurveda pharma industry

2. Quality
“Fitness for purpose”
– Juran
“Degree to which a set of inherent
characteristics fulfills requirements”
- ISO Standard

3. Importance of Quality Control
Growing interest in traditional medicines,
globally.
Huge export potential.
Consumer acceptance depends on
availability of scientific data.
Q.C forms the most essential part
in ensuring G.M.P

4. Functions of a Q.C lab
To ensure the quality of raw materials
used in medicines.
To check the finished product for the
required parameters.
To ensure that the product is being
manufactured as per G.M.P standards.

5. Raw material analysis
Physico Chemical Characteristics
•Raw Fresh Drugs
•Oils
•Honey
•Milk
Organoleptic Characteristics
•Taste
•Smell
•Color
•Touch

6. Raw material analysis
Physico Chemical Characteristics
Raw drugs
• Macroscopic Characteristics
• Microscopic Characteristics
Oils
• Adulteration tests
• Saponification Value
• Iodine Value
• Acid Value
• Specific Gravity
• Refractive Index

7. Raw material analysis
Physico Chemical Characteristics
Honey
• Specific Gravity
• Sugar %
• Invert Sugar
• Refractive Index
• Water %
• Ash
• Acidity
Milk
• Fat Content

8. Finished Product Analysis
Physico Chemical Characteristics
•Asavarishtam
•Kasahayam
•Thaliam and Ghrutham
•Lehyam
•Gulika
•Bhasma, Sindoram, Raskriya
•Tablets
•Ointmnets
•Syrups
Organoleptic Characteristics
•Taste
•Smell
•Color
•Touch

9. Finished Product Analysis
Physico Chemical Characteristics
Asavarishtam
• Total Solids
• Specific Gravity
• Reducing Sugar
• Non Reducing Sugar
• PH
• Alcohol Content
Kashaya
• Total Solids
• Specific Gravity
• PH

10. Finished Product Analysis
Physico Chemical Characteristics
Thailam & Ghruthm
• Refractive Index
• Acid Value
• Saponification Value
• Loss on drying
Lehyam
• Loss on drying
• Total Sugar
• PH

11. Finished Product Analysis
Physico Chemical Characteristics
Gulika
• Ash
• Acid insoluble ash
• Loss on drying
Bhasma, Sinduram, Raskriya
• Loss on drying
• Acid insoluble ash
• Powder fineness

12. Finished Product Analysis
Physico Chemical Characteristics
Tablets
•Disintegration Test
•Friability Test
•Hardness
•Thickness
Ointments
•Color
•Fineness
Syrups
•PH
•Sugar
•Specific Gravity

13. Instruments & Apparatus
Moisture balance
PH meter
Milk tester
Alcohol determination apparatus
Refractometer
T.S machine
Disintegration test apparatus
Hardness tester
Tablet friability test apparatus
Clevenger’s apparatus

14. Instruments & Apparatus
contd…
Rotavapour{Rotary vaccum evaporator}
Soxhlet apparatus
TLC apparatus
Microtome
Melting point determination apparatus
Boiling point determination apparatus
Viscometer
Polarimeter
Muffle furnace
Hot air oven

15. Instruments & Apparatus
contd…
Centrifuge machine
Limit test apparatus
Vaccum dessicator
Mercury analyser
Photocolcrimeter
Spectrphotometer

16. Divisions in a Q.C lab
• Phytochemistry lab
• Pharmacognosy lab
• Microbiology lab

17. Phytochemistry lab
• Estimation of alcohol content, volatile
oils, total ash, acid insoluble ash,
solubility, saponification value,
moisture content, viscosity,etc
• Determination of b.p, m.p, PH,
powder size, optical rotation,
disintegration time etc
• Chromatographic identification
• Test for heavy metals etc

18. Pharmacognosy lab
• Macroscopic and microscopic
identification of crude and
powdered drugs
• Mesurment of cell size and drawing
of microscopic structure

19. Microbiology lab
• For microbial limit test,
• Total bacterial count,total fungal
count etc
• Culture and sensitivity tests
• Identification of pathogenic strains
• To determine antimicribial activity of
drugs

20. Determination of various
parameters
• Determination of ash value
• Determination of acid insoluble ash
• Determination of water soluble ash
• Determination of alcihol soluble
extractive
• Determination of water soluble
extractives
• Determination of moisture content
• Determination ofvolatile oils

21. Determination of various
parameters [contd…]
• Determination of alcohol content
• Determination of % of reducing
sugar
• Acid value
• Saponification value
• Iodine value
• Rancidity test[Kreis test]

22. CERTAIN INSTANT CHECKS TO
FIND ADULTERANTS
I

23. Jaggery
• Salinity checked with fuming HCL,
effervescence confirms presence
• Artificial colouring agent metanil
checked with HCL, turns into pink
colour
• Presence of hydrose checked with
silver nitrate, appearance of black
ppt immeadiately indicate high
amount of hydrose

24. Honey
• Test for adulteration with commercial
invert sugar
Fiehe’s test
Aniline chloride test

25. Ghee
• Test for adulteration with vanaspathi
can be checked instantly by reaction
with1ml 1% soln of sucrose in HCL.
Appearance of crimpson to red
colour gives positive test for
vanaspathi

26. Oils
• Presence of artificial colouring agent
by reaction with HCL
• Addition of mineral oils in coconut oil
by reaction with alcoholic potash
• Rancidity test
• Badouin’s test for adulteration with
vanaspati

27. Sugar and milk
• Essential parameters are checked for
the preferred standards
• Total solids, fat content, SNF,
lactometer reading for milk
• Ash value, moisture, amount of
calcium oxide present,amount of
extraneous matter, % of sucrose etc
for sugar