Quality Control WHO guidelines

2. Contents
• Definition of natural products
• Importance of herbal medicine
• Definitions of relevant terms
• Needs to quality control
• Problems facing the quality control
• WHO guidelines for standardization of natural
products
• Analytical procedures

3. • are chemical compound or substance
produced by a living organism
Natural products

4. Importance of Herbal medicine
• Over 80 % of world population depends upon
traditional herbal medicines
• Plant based medicines 62 billion $
(globalmarket)
• Plant based medecine 1 billion US$ (indian
market)
• Annual growth up to 15 %
• Medecines account for 30-40 % of .
Health expenditure

5. 5
The definitions of terms that will be encountered in the
discussion are given:
 Quality : status of a drug that is determined by identity,
purity, content, and other chemical, physical or biological
properties
 Safety : to assure the drug didn’t have any hazardous effect
 Purity: not contaminated with potentially harmful
substances
 Potency: is the content of active constituents within the
defined limits?
 Identity: is the herb the one it should be?
 Quality control: it refers to processes involved in
maintaining the quality and validity of a manufactured
Definitions of relevant terms

6. 6
Definition continued…
 Herbal preparations
are preparations obtained by
scientific treatments such as
extraction, distillation, fractionation,
purification, or fermentation. These
include comminuted or powdered
herbal substances, tinctures, extracts,
essential oils and processed exudates

7.  Herbal substances
are precisely defined by the plant part used (leaves, stems,
rhizomes, roots and bark)
Certain exudates that have not been subjected to a specific
treatment are also considered to be herbal substances
Definition continued…

8.  Markers
are chemically defined constituents or groups of
constituents of a herbal substance, which are of interest for
control purposes, independent of whether they have any
therapeutic activity

9. Need of quality control
• Quality control standardization
• Reduce adulterations with substandard drugs
• Improper authentication
• Scientific validation of the therapeutic claims
• Identity, purity, efficacy and safety
• Customer satisfaction and confidence

11. WHO Guidelines for Quality
Control
&
Standardization of Herbal
Drugs

12. Standardization of herbal drugs crude
plant parts / plant material
Definition:
− name of plant
− part of plant
− Nature/condition of material: whole, powdered, fresh, dried, etc
Authentication/confirmation of:
− Correct geographical origin
− Correct stage of growth
Absence of foreign matter:
− other plant parts or materials
− soil, stones, dust
− insects and other animal matter (as determined by microscopy, macroscopy,
chromatography)
Microscopic characteristics confirming identity:
− qualitative features
− quantitative features, (e.g. stomatal number)
Radioactive contamination limits: arising from environmental pollution or microbial
decontamination procedures
Assay: for materials containing constituents of known therapeutic activity, or known unique
(marker) compounds. Non-specific assay methods for groups of compounds may be
used where specific assay methods are not available for single compounds
12

13. Processed plant materials/non-plant materials
(extracts, tinctures, comminutions etc.)
Definition: liquid, solid, etc
Organoleptic characteristics:
− Macroscopy
− Smell
− Taste
− Texture
− Colour
Chromatographic profile using more than one method:
− to confirm presence of unique compounds (markers)
− to confirm characteristic TLC chromatogram
− to confirm characteristic HPTLC chromatogram (TLC + densitometry = HPTLC)
Water content (for hygroscopic materials):
Ash values: indicate extent of contamination with inorganic material.
Determined by
incineration. Values include acid insoluble and sulphated ash
Volatile matter: for plants containing volatile oils:
− Determined by steam
− Distillation
Powdered material: test method and acceptable limits for particle size, distribution
13

14. continued...
If the product is a mix of plant materials, the supplier must provide evidence
that each
component plant has been individually tested.
Heavy metal limits: from environmental pollution and pesticides
Microbial contamination limits: microbial contamination arises from
cultivation,
harvesting, processing and storage:
− confirmation of absence of E. coli, S. aureus, P. aeruginosa and
− Salmonella
− limits for aflatoxins (fungal toxins)
Residual solvents from processing
Pesticide residue limits: arising from cultivation (FAO and WHO limits)
Extractive values: extraction by different solvents indicates proportion of
polar and
non-polar components
Assay: for materials containing constituents of known therapeutic activity, or
known
unique (marker) compounds;
− Non-specific assay methods for groups of compounds may be used14

16. Analytical procedures
Botanical parameters:
– Sensory evaluation: including visual macroscopy/
touch/odour/taste
– Foreign matter: including foreign plants, foreign
animals, foreign minerals, etc.
– Microscopy: including histological observation
and measurements
16
*Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
** Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier
Pub., 2006.

17. continued…
Physico-chemical methods:
− Ash values: Total, acid insoluble, water soluble
− Extractive values: in hot water, cold water and
ethanol,
− Volatile matter: Loss on drying,
− Volatile oils: by steam distillation.
− Determination of crude fibers,
− Determination of moisture content.
17

18. continued…
Biological parameters:
− Bitterness value: unit equivalent bitterness of
standard solution of Quinine HCI
− Hemolytic property: on ox blood by comparison
with standard reference solution of saponin
− Astringent property: tannins that bind to standard
Frieberg Hide powder
− Swelling index: in water
− Foaming index: foam height produced by 1g
material under specified conditions
18

19. continued…
Toxicological parameters:
These include the various identification
procedures:
− Arsenic: stain produced on HgBr2 paper in
comparison to standard stain
− Pesticide residues: including total organic
chloride and total organic phosphorus
− Heavy metals: like cadmium, mercury and lead
− Microbial contaminations: total viable aerobic
count of pathogens; viz. Enterobacteriaceae, E.
Coli, Salmonella, P. aeruginosa, S. aureous, (e.g.
Mellilotus officinalis)*
− Aflatoxins: by TLC using standard aflatoxins (B1,
B2, G1 and G2)
− Radioactive contaminations
19
*Warude D., Patwardhan B. Quality and Regulatory Issues. Journal of Scientific
and Industrial Research. Vol. 64, Feb 2005; p. 83-92.

20. References
− Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
− EMEA. Guidelines on Quality of Herbal Medicinal
Products/Traditional Medicinal Products, EMEA/CVMP/814OO
Review. European Agency for the Evaluation of Medicinal Products
(EMEA), London, 2005.
− Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to
Evaluation of Botanicals. Business Horizons Publishers, New Delhi,
India, 2002.
− Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I ,
Carrier Pub., 2006.
− Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality
control principles to herbal drugs. International Journal of
Phytomedicine 1(2009); p. 4-8.
− WHO. Quality Control Methods for Medicinal Plant Materials, World
Health Organization, Geneva, 1998. WHO. Guidelines for the
Appropriate Use of Herbal Medicines. WHO Regional Publications,
Western Pacific Series No 3, WHO Regional office for the Western20

21. continued…
− WHO. The International Pharmacopeia, Vol. 2: Quality
Specifications, 3rd edn. World Health Organization, Geneva,
1981.
− WHO. Quality Control Methods for Medicinal Plant Materials.
World Health Organization, Geneva, 1999.
− WHO. WHO Global Atlas of Traditional, Complementary and
Alternative Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2,
maps. World Health Organization, Geneva, 2005.
− WHO. Guidelines on Good Agricultural and Collection Practices
(GACP) for Medicinal Plants. World Health Organization,
Geneva, 2004.
− Warude D., Patwardhan B. Batanicals: Quality and Regulatory
Issues. Journal of Scientific and Industrial Research. Vol. 64, Feb
2005; p. 83-92.
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22. − The World Health Organization (WHO) is a specialized
agency of the United Nations (UN) that is concerned with
international public health
− It was established on 7 April 1948, with its headquarters
in Geneva, Switzerland
− WHO is a member of the United Nations Development
Group (UNDP)
− World Health Organization, provides guidelines for
prevention, control, safety, efficacy as well as evaluation
and standardisation of herbal materials (e.g. WHO, 2005,
2002a,b, 1999a,b, 1998a,b, 1996a,b, 1990, 1981, 1979)

23. THANK
YOU
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