1. Scholar
Dr.Bidhan Mahajon
Guide
Dr. Remadevi.R. MD(AYU)
Professor and H.O.D
1
Department of Dravyaguna Vijnanam
V.P.S.V. Ayurveda College
Kottakkal

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

5. 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.”

6. QUALITY
Quality of a medicinal product is measured by
it’s fitness for purpose

7. Quality Control And
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

9. 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

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

11. • In India, the Schedule T of Drug and
Cosmetic Act of 1940 deals with the
license to be issued to the manufacturer
with GMP standards

12. GMP HERBAL MEDICINES NORMS
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
1. Quality assurance 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

13. 1. 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

14. 2. 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

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

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

17. 5. Complaints
COMPLAINTS
PRODUCT
QUALITY
COMPLAINT
ADVERSE REACTION

18. 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.

19. 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

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

21. 7. 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.

22. 8. SELF - INSPECTION
• The purpose of selfinspection is to evaluate the
manufacturer’s compliance
with GMP in all aspects of
production and quality
control

23. 9. 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

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

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

26. 11. 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.

27. 12. 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)

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

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

30. 14. 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

31. 15. 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

32. 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

33. 16. 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

34. 17. GOOD PRACTICES IN QUALITY
CONTROL
GENERAL
• 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

35. 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

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

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

38. 
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
•

39. Good Laboratory Practices

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

41. 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

42. 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

43. 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

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

45. Documentation
• 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!!

46. 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-ofcustody, sample or chemical receipt)
• Training reports
• Computer printouts
• Recorded data from automated instruments

47. Raw Data
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).

49. 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.

50. Standard Operating Procedures (SOP)
• They define how to carry out protocolspecified activities.
• Most often written in a chronological listing of
action steps.
• They are written to explain how the
procedures are suppose to work

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

52. Thank
u