Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers.

1. Dr. Ashwani Dhingra
9996230055
ashwani1683@gnkgei.ac.in
Quality
Assurance
in Herbal
Drug
Industry

2. Good Agricultural and
Cultivation
Practices(GACP)
Good Laboratory
Practices (GLP)
Good clinical
practices(GCP)
Good Manufacturing
Practices(GMP)

4. WHAT IS GMP?
WHO defines Good
Manufacturing
Practices (GMP) as “that part
of quality assurance
which ensures that products
are consistently produced
and controlled to the
quality standards
appropriate to their intended
use and as required by the
marketing authorization.”
What is GMP?

5. WHAT IS QUALITY ?

6. Quality Control Vs.
Quality Assurance
• Operational
laboratory
techniques and
activities used to
fulfill the
requirement of
Quality
• QC is lab based
• All those planned or
systematic actions
necessary to provide
adequate confidence
that a product will
satisfy the requirements
for quality
• QA is company based

8. GMP helps to boost pharmaceutical
export opportunities
• Most countries will only
accept import and sale of
medicines that have been
manufactured to
internationally recognized
GMP

9. • ICH www.ich.org
• WHO www.who.int
• USFDA www.fda.gov
• EU www.emea.europa.eu
Certifying agencies

10. Schedule T Drug and Cosmetic
Act of 1940

11. GMP
HERBAL
MEDICINES
NORMS
1. QA in the manufacture of herbal medicines
2. Good manufacturing practice for herbal medicines
3. Sanitation and hygiene
4. Qualification and validation
5. Complaints
6. Product recalls
7. Contract production and analysis
8. Self-inspection
9. Personnel
10. Training
11. Personal hygiene
12. Premises
13. Equipments
14. Materials
15. Documentation
16. Good practices in production
17. Good practices in quality control

12. QUALITY ASSURANCE IN THE
MANUFACTURE OF HERBAL MEDICINES
Quality assurance”- is a wide-ranging
concept covering all matters that
individually or collectively influence the
quality of a product

13. GOOD
MANUFACTURING
PRACTICE FOR
HERBAL MEDICINE
• First step- cultivation
and collection of
medicinal plants
• This ensures the quality,
safety and efficacy of the
complex products of biological
origin

14. Sanitation
and Hygiene
• A high level of
sanitation and hygiene
during manufacture is
necessary because
herbal products are
prone to contamination

15. Qualification
and validation
Qualification of critical
equipment process
validation are particularly
important in the
production of herbal
medicines with unknown
therapeutically active
constituents

16. Complaints
PRODUCT QUALITY
COMPLAINT
ADVERSE REACTION

17. PRODUCT QUALITY COMPLAINTS
causes – faulty manufacture,
product defects or
deterioration, adulteration of
the herbal material
The complaints should be recorded in detail and the
causes thoroughly investigated (e.g. by comparison
with the reference samples kept from the same
batch)
There should be written procedures to describe the
action to be taken.

18. ADVERSE REACTION/ EVENTS
Reports of any adverse reaction/event should be entered in a
separate register in accordance with national and international
requirements
An investigation should be conducted to find out whether the
adverse reaction/event is due to a quality problem and whether such
reactions/events have already been reported in the literature or
whether it is a new observation
Complaint records should be reviewed regularly to detect any
specific or recurring problems requiring special attention and
possible recall of marketed products
The WHO guidelines on safety monitoring of herbal medicines
in pharmacovigilance systems deal with specific issues relating
to adverse reactions and adverse events following treatment
with herbal medicines

19. PRODUCT RECALL
There should be a system to recall
from the market, promptly and
effectively, products known or
suspected to be defective.

20. CONTRACT PRODUCTION AND
ANALYSIS
Contract production and
analysis must be correctly
defined, agreed and
controlled in order to avoid
misunderstandings that could
result in a product or work or
analysis of unsatisfactory
quality.

21. SELF -INSPECTION
The purpose of self-
inspection is to
evaluate the
manufacturer’s
compliance with
GMP in all aspects of
production and
quality control

22. PERSONNEL
•The manufacturer should have an
adequate number of personnel with the
necessary qualifications and practical
experience.
•All personnel should be aware of the
principles of GMP that affect them and
receive initial and continuing training,
including hygiene instructions, relevant
to their needs.
•All personnel should be motivated to
support the establishment and
maintenance of high quality standards

23. • Key personnel
Key personnel include
The heads of production and quality control should
be independent of each other

24. TRAINING
• The personnel should have
adequate training in
appropriate fields such as
pharmaceutical technology,
taxono micbotany,
• Phytochemistry,
pharmacognosy, hygiene,
microbiology and related
subjects

25. PERSONAL HYGENE
• Personnel must be protected from
contact with toxic irritants and
potentially allergenic plant
materials by means of adequate
protective clothing
• They should wear suitable gloves,
caps, masks, work suits and shoes
throughout the whole procedure
from plant processing to product
manufacture.

26. PREMISES
STORAGE AREAS
• Storage areas should be well
organized and tidy.
• Herbal materials,
including raw herbal
materials, should be kept
in a dry area protected
from moisture and
processed following the
principle of “first in, first
out” (FIFO)

27. To facilitate cleaning
and to avoid cross-
contamination,
adequate
precautions should be
taken during the
sampling, weighing,
mixing and processing
of medicinal plants
PRODUCTION AREA

28. EQUIPMENTS
• Processing of herbal materials
may generate dust or material
which is susceptible to pest-
infestation or microbiological
contamination and cross
contamination
• Vacuum or wet-cleaning
methods are preferred
• Non-wooden equipment should
be used unless tradition
demands wooden material

29. MATERIALS
All incoming herbal
materials should be
quarantined and stored
under appropriate
conditions
Only permitted substances
should be used for
fumigation
Reference samples and
standards

30. DOCUMENTATION
Herbal materials
• The family and botanical
name of the plant used
according to the
binomial system
• The vernacular name
and the therapeutic use
in the country or region
of origin of the plant

31. Finished
herbal
products
Tests for microbiological
contamination and tests for other
toxicants
Uniformity of weight, disintegration
time, hardness and friability,
viscosity, consistency and dissolution
should be documented
Physical appearance such as colour,
odour, form, shape, size and texture
Identity tests, qualitative
determination of relevant
substances of the plants

32. GOOD
PRACTICES IN
PRODUCTION
Collection/cultivation and
/or harvesting of medicinal
plants should follow the
WHO Guideline on good
agriculture and collection
practices (GACP) for
medicinal plants

33. GOOD PRACTICES IN QUALITY CONTROL
The personnel of quality control units
should have the necessary expertise in
herbal medicines to enable them to
carry out identification tests and
recognize adulteration, the presence of
fungal growth or infestations and lack
of uniformity in a consignment of
herbal materials

34. SAMPLING
• Herbal materials should have an element
of heterogeneity, so sampling should be
carried out with special care by personnel
TESTING
• The identity and quality of herbal material,
herbal preparations and of finished herbal
products should be tested as described in
the Quality control methods for medicinal
plant materials
• Reference samples of herbal materials
should be made available for use in
comparative tests

35. Packaging
materials and
labelling
All packaging
materials, such
as bottles and
other materials,
should be stored
properly

36. LABELING AND PACKING
All finished drug products should be
identified by labeling bears at least the
following information:
’

37. • The name of the drug product
• a list of the active ingredients
showing the amount of each present
and a statement of the net contents
• the batch number assigned by the
manufacturer; the expiry date
• any special storage conditions or
handling precautions that may be
necessary
• directions for use, and warnings and
precautions that may be necessary
• the name and address of the
manufacturer or the company or the
person responsible for placing the
product on the market
LABELING
INFORMATION

38. Good
Laboratory
Practices

39. GLP embodies a set of
principles that provides
a framework within
which laboratory
studies are planned,
performed, monitored,
reported and archived.

40. Scope
of GLP
• GLP should be applied to the
non-clinical safety testing of
test items:
» Pharmaceutical product
» Pesticides product
» Cosmetic product
» Food additives
» Feed additives
» Industrial chemical
• in the Laboratory, in
greenhouses or in the field

41. What Role Do GLPs Play?
• Good Laboratory
Practice standards
help to assure the
quality and
integrity of studies
submitted in
support of FDA
regulated
products

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

43. Documentation
If you didn’t write it
down, it NEVER
happened.

44. • Record data using permanent ink (never pencil)
• Date and sign every entry (who is responsible?)
• Keep records in “real time” (no catching up later)
• No rewrites, need original entries (reduces
transcription errors)
Documentation is important in all
sorts of situations!!
Documentation

45. Raw Data
• Can you list examples of raw data?
• Logbooks (to record temperatures or equipment use,
repair, and maintenance)
• Field or laboratory notebooks
• Forms (for field or laboratory observations, chain-of-
custody, sample or chemical receipt)
• Training reports
• Computer printouts
• Recorded data from automated instruments

46. Question:
What happens if you make
a mistake?
Answer:
Do not obscure original data!! Instead, draw a single strikeout,
then add reason code, initials, and date of change. (Preserve
the original data).
Raw Data

48. Standard Operating
Procedures (SOPs)
SOPs are written, approved procedures that
describe routine activities that are specific for
daily operations at each facility.
SOPs should allow appropriately qualified
personnel to perform a procedure once trained.

49. • 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
Standard Operating
Procedures (SOPs)

50. Websites
• Code of Federal Regulations (CFR)- all
• EPA GLP Regulations
• FDA GLP Regulations
• USDA- Pesticide Data Program (PDP) Standard
Operating Procedures

51. Thank you