1. RRRRRRRRRRRRNJNBKMNLKGR
JSS Academy of Higher Education & Research
(Deemed to be University)
Accredited ‘A’ Grade by NAAC
Sri Shivarathreeshwara Nagara, Mysuru – 570 015
Karnataka, INDIA
Quality assurance in
Herbal/Natural drug products
Prepared By
Ramkishan Jatoth,
PhD Research Scholar,
Dept. Pharmacognosy and Phyto pharmacy
JSS College of Pharmacy, Rockland’s, Ooty-01, Tamil
Nadu, India.
2. HERB
ARE - crude plant material such as leaves, flowers, fruit, seed,
stems, wood, bark, roots, rhizomes or other plant parts, which may be
entire, fragmented or powdered.
HERBAL DRUGS/ HERBAL FORMULATION
ARE – Finished labelled products that contain active
ingredients such as aerial or underground parts of plant or other
plant material or combinations there of, whether in the crude state
or as plant preparations.
3. Quality Assurance
Q C is an operation undertaken in a laboratory to analyze a sample
or material within the known probability limits of accuracy and
precision while Q.A. is defined as system through which laboratory
conducts the analysis , the proof of which lies in documentation.
Corrective Actions are taken under the ‘Act’ when any batch of drug
fails during inspection.
4. WHO Guidelines for Quality Control of Herbal
formulation
• Quality control of crude drugs material, plant preparations
and finished products.
• Stability assessment and shelf life.
• Safety assessment; documentation of safety based on
experience or toxicological studies.
• Assessment of efficacy by pharmacological
information and biological activity evaluations.
5. STANDARDISATION
• Standardization of drug means
• “confirmation of its identity and
determination of its quality and purity and detection of
nature of adulterant by various parameters like
morphological, microscopical, physical, chemical and
biological observations.”
6. STANDARDISATION
OF HERBAL DRUGS
• Moist. Cont.
• Extrac. Values
• Ash Values
• Fluores.Analy.
• Qualitative
• Quantitative
• SEM Studies
• Powder Studies
•Shape
•External
•Marking
• Colour
• Odour
• Taste
• Texture
• Fracture
Antagonistic
Microbial
Contamination
A) Total viable
aerobic count
B) Determination
of pathogens
C) Aflatoxins
content
• Pharmacological
Bitterness value
Haemolytic activity
Foaming index
Swelling index
• Toxicological
Determination of
pesticide residues
Determination of heavy
metals
•Bacterial
• Fungal
•Qualitative
• Quantitative
• Chromatography
• Radioactive contamination
HPTLC
GLC
HPLC
HPTLC Finger printing
Sec. Metabolites
DNA Finger printing
Macroscopic
2
7. ANALYTICAL SPECIFICATIONS OF VATI/
GUTIKA (TABLET/PILLS)
1. Description
Colour
Odour
2. Weightvariation
3. Disintegrationtime-Notmorethan15 min
4. IdentificationTLC/HPTLC/GLC
5. Assay
6. Testforheavy/Toxicmetals
Lead
Cadmium
Mercury
Arsenic
