Quality Assurance:

Quality assurance of herbal medicinal products is the shared responsibility of

manufacturers and regulatory bodies. National drug regulatory authorities have
to establish guidelines on all elements of quality assurance, evaluate dossiers
and data submitted by the producers, and check post-marketing compliance of
products with the specifications set out by the producers as well as compliance
with Good Manufacturing Practices (GMP). The manufacturers have to adhere
to Good Agricultural and Collection Practices (GACP), GMP, and Good
Laboratory Practice (GLP) standards, establish appropriate specifications for
their products, intermediates, and starting materials, and compute a well-
structured, comprehensive documentation on pharmaceutical development and
testing. The producers should make continued efforts to improve standards and
adapt them to the present state of knowledge. A cooperative approach between
different manufacturers, e.g. by establishing drug master files for specifications
and quality control, should be encouraged.
Elements of Quality assurance are:
(a) Adherence to GACP, GMP, and GLP guidelines
(b) Setting specifications
(c) Quality control measures
Current Good Manufacturing Practice (cGMP)
cGMP refers to the Current Good Manufacturing Practice regulations imposed
by the FDA. cGMP assures proper design, monitoring, and control of
manufacturing processes and facilities in the herbal drug industry. It also
includes; establishing strong quality management systems, obtaining the right
quality of raw materials, establishing robust operating procedures, detecting and
investigating product quality, and maintaining reliable testing laboratories. If
put into practice, this type of control method at a pharmaceutical company helps
prevent contamination, mix-ups, deviations, failures, and errors. Thus, it assures
drug products meet the Current Good Manufacturing Practice regulations.
Highly trained FDA staff inspect pharmaceutical manufacturing facilities
worldwide including; facilities that manufacture active ingredients and the
finished product. If a company does not comply with cGMP regulations, any
drug it makes is considered "adulterated" under the law.
Objectives of cGMP:
 cGMP regulations assure that quality is built into the design and
manufacturing process at every step.
  Manufacturing facilities are in good condition.
 Equipment is properly maintained and calibrated.
 Employees are qualified and fully trained.
 Processes that are reliable and reproducible.
General guidelines on cGMP for medicinal plants:
The FDA's drug manufacturing inspection compliance program contains
instructions to FDA personnel for conducting inspections, is a systems-based
approach to inspection, and is very consistent with the robust quality system
model presented in this guidance. The diagram below shows the relationship
between the six systems:

Six-system Inspection Model

(a) Quality System: Every pharmaceutical product has to establish identity,
strength, purity, and other quality characteristics to ensure the required
levels of safety and effectiveness. It includes all product defect
evaluations and returned and salvaged drug product evaluations.
(b)Production System: This system includes measures and activities to
control the manufacture of drugs and drug products including; batch
compounding, dosage form production, in-process sampling and testing,
and process validation. It also includes; establishing, following, and
documenting the performance of approved manufacturing procedures.
 (c) Facilities and Equipment System: This includes; the measures and
activities that provide a proper physical environment and resources used
in producing the drugs or drug products. It includes:
a. Buildings and facilities along with maintenance.
b. Equipment qualifications (installation and operation).
c. Equipment calibration and preventative maintenance.
d. Cleaning and validation of cleaning processes.
Utilities not intended to be incorporated into the product include
heating, ventilation, and air conditioning (HVAC), compressed gases,
steam, and water systems.
(d)Laboratory Control System: This system includes; measures and
activities related to laboratory procedures, testing, analytical methods
development and validation or verification, and the stability program.
(e) Materials System: It includes measures and activities to control finished
products, components including; water or gases that are incorporated into
the product, containers, and closures. It also includes; validation of
computerized inventory control processes, drug storage, distribution
controls, and records.
(f) Packaging and Labeling System: This system includes; measures and
activities that control the packaging and labeling of drugs and drug
products. It includes; written procedures, label examination and usage,
label storage and issuance, packaging and labeling operations controls
and validation of these operations.
Good Agricultural Practice (GAP)
A Good Agricultural Practice of medicinal plants is a cultivation program
designed to ensure optimal yield regarding the quality and quantity of any crop
intended for health purposes. The guidelines on Good Agricultural Practices
(GAP) provide documented proof of handling medicinal plants right from
cultivation to post-harvesting operations. Raw medicinal plant materials should
meet all applicable national or regional quality standards. The guidelines,
therefore, may need to be adjusted according to each country's situation.
Objectives of GAP:
 To contribute to the quality assurance of medicinal plant materials used as
the source for herbal medicines, which aims to improve the quality, safety
and efficacy of finished herbal products.
  To guide the formulation of national or regional guidelines and
monographs for medicinal plants and related standard operating
procedures (SOPs).
 To encourage and support the sustainable cultivation and collection of
medicinal plants of good quality that respect and support the conservation
of medicinal plants and the environment in general.
The safety and quality of raw medicinal plant materials and finished products
depend on factors that may be classified as intrinsic (genetic) or extrinsic
(environment, collection methods, cultivation, harvest, post-harvest processing,
transport, and storage practices). Accidental contamination by microbial or
chemical agents during any of the production stages can also lead to
deterioration in safety and quality. Medicinal plants collected from the wild
population may be contaminated by other species or plant parts through
misidentification, accidental contamination, or intentional adulteration, all of
which may have unsafe consequences.
PRINCIPLES OF GAP:

GAP Pillar 1: Economic Viability:

• This means to maintain viable farming enterprises and contribute to
sustainable livelihoods.
• Generally, it refers to the profit earned from the management of
productive land.
• Demonstrate this pillar by providing sufficient evidence on the viability
of farm operations such as management reviews, annual reports, and
financial plans.
GAP Pillar 2: Environmental Stability
• This means to sustain and enhance the natural resource base.
 • The most recent Good Agricultural Practices manual outlines critical
requirements such as assessing the risk of causing environmental harm on
and off new sites, keeping records of the hazards assessed, and detailing
the chemicals used to sterilize soils and substrates.
• Moreover, the GAP manual indicates major requirements for
environmental management.
GAP Pillar 3: Social Acceptability
• This means to meet the cultural and social demands of society.
• An essential way of practicing this principle is to protect the agricultural
workers’ health from hazards brought on by the improper use of
chemicals and pesticides.
• They should also be trained on the appropriate knowledge and skills for
correct handling and application of hazardous materials.
GAP Pillar 4: Food Safety and Quality
• This means to economically and efficiently produce sufficient, safe, and
nutritious food.
• Control should begin in the field to reduce the hazards of contamination.
• To take action on this commitment, evaluate the elements of safety, and
produce quality modules of GAP for fruits and vegetables.
General guidelines on GAP for medicinal plants:
(a) Selection of medicinal plants: The species or botanical variety selected
for cultivation should be the same as that specified in the National
pharmacopoeia or recommended by other authoritative national
documents of the end user's country. In the absence of such national
documents. the selection of species or botanical varieties specified in the
pharmacopoeia or other authoritative documents of other countries should
be considered. In the case of newly introduced medicinal plants, the
species or botanical variety selected for cultivation should be identified
and documented as the source material used or described in the traditional
medicine of the original country.
(b) Identification/authentication of cultivated medicinal plants: The
botanical identity scientific name (genus, species, subspecies/variety,
author and family) of each medicinal plant under cultivation should be
verified and recorded. The local and English common names should also
be recorded. Other relevant information such as; the cultivar name,
 ecotype, chemotype or phenotype, may also be provided, as appropriate.
For commercially available cultivars, the name of the cultivar and of the
supplier should be provided. In the case of landraces collected,
propagated, distributed and grown in a specific region, records should be
kept of the local name including; the origin of the source of seeds, plants
or propagating materials.
(c) Specimens: In case of the first registration of a medicinal plant or where
reasonable doubt exists as to the identity of a botanical species, a voucher
botanical WHO guidelines on good agricultural and collection practices
(GACP) for medicinal plants specimen should be submitted to a regional
or national herbarium for identification. Wherever possible, a genetic
pattern should be compared to that of an authentic specimen.
Documentation of the botanical identity should be included in the
registration file.
(d) Seeds and other propagating materials: Seeds and other propagating
materials should be specified and the suppliers should provide all
necessary information relating to the identity, quality, and performance of
their products, as well as their breeding history. The propagating or
planting materials should be of the appropriate quality and free from
contamination and diseases to promote healthy plant growth. Planting
material should preferably be resistant or tolerant to biotic or abiotic
factors. The quality of propagating material including; any genetically
modified germplasm should comply with regional or national regulations
and be correctly labeled and documented, as required. Care should be
taken to exclude extraneous species and botanical varieties during the
entire production process. Counterfeit, substandard and adulterated
propagation materials must be avoided.
(e) Cultivation: The cultivation of medicinal plants requires intensive care
and management. The conditions and duration of cultivation required
differ depending on the quality of medicinal plant materials. If no
scientific published or documented cultivation data are available.
traditional methods of cultivation should be followed. Otherwise. a
method should be developed through research.
(f) Site selection: Medicinal plant materials derived from the same species
can show significant differences in quality when cultivated at different
sites, due to the influence of soil, climate and other factors. These
differences may relate to physical appearance or variations in their
constituents. Risks of contamination as a result of pollution of the soil, air
or water by hazardous chemicals should be avoided. The impact of p.ast
 land uses on the cultivation site including; the planting of previous crops
and any applications of plant protection products, should be evaluated.
(g) Ecological environment and social impact: The cultivation of
medicinal plants may affect the ecological balance and the genetic
diversity of the flora and fauna in surrounding habitats. The quality and
growth of medicinal plants can also be affected by other plants, other
living organisms and by human activities. The introduction of non-
indigenous medicinal plant species into cultivation may harm the
biological and ecological balance of the region. The ecological impact on
cultivation should be monitored over time.
(h) The social impact of cultivation on local communities: It should be
examined to ensure that negative impacts on local livelihood are avoided.
In terms of local income opportunities, small scale cultivation is often
preferable to large scale production. If large-scale medicinal plant
cultivation has been established, care should be taken that local
communities benefit directly from it like; fair wages, equal employment
opportunities and capital reinvestment.
(i) Climate: Climatic conditions like; the length of day, rainfall (water
supply) and field temperature significantly influence the physical,
chemical and biological qualities of medicinal plants. The duration of
sunlight. average rainfall. average temperature including; daytime and
nighttime temperature differences, also influence the physiological and
biochemical activities of plants.
(j) Soil: The soil should contain appropriate amounts of nutrients, organic
matter and other elements. to ensure optimal medicinal plant growth and
quality. Optimal soil condition includes; soil type, drainage, moisture
retention, fertility and pH. The use of fertilizers is vital in order to obtain
large yields of medicinal plants. Human excreta must not be used as a
fertilizer due to the presence of infectious micro-organisms or parasites.
Any applications of animal manure should be documented and used per
the needs of the medicinal plant species. Chemical fertilizers that have
been approved by the countries of cultivation and consumption should be
used.
(k) Irrigation and drainage: Irrigation and drainage should be controlled
and carried out per the needs of the individual medicinal plant species
during its various stages of growth. Water used for irrigation purposes
should comply with local, regional and national quality standards. Care
should be exercised to ensure that the plants under cultivation are neither
over nor under-watered.
(l) Plant maintenance and protection: The growth and development of
individual medicinal plants, as well as the plant parts intended for
medicinal use, should be taken more care and maintained. The timely
application of measures such as; topping, bud nipping, pruning and
shading may be used to improve the quality and quantity of the medicinal
plant. Agrochemicals used to protect medicinal plants should be kept to a
minimum and applied only when no alternative measures are available.
When necessary, only approved pesticides and herbicides should be
applied at the minimum effective level, per the labeling and instructions
of regulatory bodies. Only qualified staff using approved equipment
should carry out pesticide and herbicide applications. All applications
should be documented.
(m) Harvesting and Drying: Medicinal plants should
be harvested during the optimal season or time to ensure maximum yield
of the active constituents and the best possible quality. The time of
harvest depends on the plant parts to be used. During harvest, care should
be taken to ensure that no foreign matter, weeds, or toxic plants are mixed
with the harvested medicinal plant materials. Medicinal plants should be
harvested under the best possible conditions, avoiding dew, rain, or high
humidity. If harvesting occurs in wet conditions, the harvested material
should be transported immediately to an indoor drying facility to
accelerate drying to prevent any possible deleterious effects due to
increased moisture levels, which promote microbial fermentation and
mold. Cutting devices, harvesters, and other machines should be kept
clean and adjusted to reduce damage and contamination from soil and
other materials. If the underground parts (such as; the roots) are used, any
adhering soil should be removed from the medicinal plant parts as soon as
they are harvested. The harvested raw medicinal plant materials should be
transported in clean and dry conditions. They may be placed in clean
baskets, dry sacks, trailers, hoppers, or other well· aerated containers and
carried to a central point for transport to the processing facility. All
containers used should be kept clean and free from contamination by
previously harvested medicinal plants and other foreign matter. If plastic
containers are used attention should be paid to any possible retention of
moisture that could lead to the growth of mold. Decomposed medicinal
plant materials should be identified and discarded during harvest, post-
harvest inspections, and processing, to avoid microbial contamination and
loss of product quality.
(n) Storage: Organically grown medicinal plant materials should be stored
and transported separately in a manner that ensures their integrity. Fresh
 medicinal plants should be stored at low temperatures, ideally, at 2-8'C,
frozen products should be stored at less than -20•c.
(o) Personnel: Growers and producers should have adequate knowledge of
the medicinal plant concerned. This should include; botanical
identification, cultivation characteristics and environmental requirements
(soil type, soil pH, fertility, plant spacing, and light requirements), and
methods of harvesting and storage. All personnel (including; field
workers) involved in the propagation, cultivation, harvest, and post-
harvest processing stages of medicinal plant production should maintain
appropriate personal hygiene and should have received training regarding
their hygiene responsibilities. They should receive instruction on all
issues relevant to the protection of the environment, conservation of
medicinal plant species, and proper agricultural stewardship.
GOOD MANUFACTURING PRACTICE (GMP)
Herbal medicines are prepared from materials of herbal origin, which are
often obtained from different geographical and/or commercial sources. As
a result, it may not always be possible to determine the conditions to
which, they may have been subjected as well as they may vary in
composition and properties. Good Manufacturing Practices (GMP) is part
of quality assurance, which ensures that products are regularly produced
and controlled according to the quality standards suitable for their use.
Herbal drugs are considered to be adulterated if GMPs are not met. GMP
standards are the only guidelines, alternative processes, and control
mechanisms that can be used as an essential tool to assure quality.
Objectives of GMP:
 Raw materials used in the manufacture of drugs are authentic, of
prescribed quality, and free from contamination.
 The manufacturing process has been prescribed to maintain the
standards.
 Adequate quality control measures are adopted.
 The manufactured drug which is released for sale is of acceptable
quality.
GENERAL REQUIREMENTS TO ESTABLISH GMP FOR MEDICINAL
PLANTS:
(a) Infrastructural requirements:
The manufacturing plant should have adequate space for
manufacturing process areas, a quality control section and finished
goods store, receiving and storing raw material office, an office for
 rejected goods/drugs store, etc. Location and surroundings of the
pharmacy should be situated where there is:
• No open sewage.
• No drainage coming from public areas and public
lavatory.
• No factory fumes.
• No excessive soot, smoke and dust.
(b)Buildings:
• Buildings should be in hygienic condition.
• No cobwebs/insects/rodents.
• Sufficient light, ventilation, and working space.
• No dampness or moisture should be there on the floor and
walls.
• Wall and floors should be even.
• Premises used for manufacturing, processing, packaging,
and labeling should be according to the provisions of the
Factory Act.
• Proper placement of equipment to avoid risk of mixing
and cross-contamination.
• Designed, constructed, and maintained well to prevent the
entry of insects/rodents.
• The Interior surface should be smooth, and easy for
cleaning and disinfection.
• The parking bay should be smooth and even so as not to
permit retention or accumulation of dust or waste
products.
(c) Proper drainage system:
• Sanitary fittings and electrical fixtures should be used for
safety.
• The furnace section should be covered with a tin roof.
• Proper ventilation/chimney in the factory.
• Prevention of flies and dust in factory premises.
• Proper fire safety measures/exits should be installed.
(d)Water Supply:
The water used in manufacturing should be pure and of potable
quality. An adequate supply of water is required for washing the
premises and containers.
(e) Disposal of Waste:
 In the manufacturing section and laboratories, the wastewater and
residues are disposed of after suitable treatment as per the guidelines
of pollution control to be followed.
(f) Containers. Cleaning:
Adequate arrangements for washing, cleaning, and drying of
containers should be there.
(g) Stores:
There should be sufficient space for stores of different types of
materials such as; raw materials, packing materials, and finished
products. The store should have proper ventilation and should be free
from dampness.
1. Raw materials stores: Raw materials stores should have
appropriate containers that would protect the quality of raw
materials and prevent contamination, rodents, and insects.
Suitable cabins should be maintained for raw materials of
metallic, mineral, animal origin, fresh herbs, dry herbs, plant
parts, excipients, volatile oils/perfumes, flavors, plant extracts,
exudates/resins, etc. Each container used for raw material storage
should be identified with a label that indicates the name of the
raw material, and source of supply and should also clearly state
the status of raw material such as; under test or Approved or
Rejected. Records of the receipt, testing, and approval or
rejection should be maintained.
2. Packing materials stores: All packing materials such as; bottles,
jars, capsules, etc. should be stored properly. All the containers
and closure lids should be properly cleaned and dried before
packing the products.
3. Finished goods stores: The finished goods are transferred from
the production area. after proper packaging should be stored on
proper shelves within an area marked "Quarantine". After the
quality control laboratory test and the experts have checked the
correctness of finished goods then it should be moved to the
approved finished goods stock area. Only approved finished
goods should be dispatched as per marketing requirements.
(a) Working Space:
The manufacturing area should provide adequate space for the organized
placement of equipment and materials used in any of the operations.
There should be proper facilities for easy and safe working. Facilities to
minimize or eliminate mixing up of the drugs should be provided to
prevent cross-contamination of one drug by another drug that is
manufactured, stored, and handled on the same premises.
(b) Health. clothing, sanitation, and hygiene:
Workers should be free from contagious diseases. They should wear
proper uniforms suitable for work. Hands should be covered with cloth
or synthetic covering. Personal cleanliness, clean towels, soap,
scrubbing brushes, and separate lavatories for men and women should
be maintained. Facility for changing clothes and cupboards to keep their
clothes and belongings should be provided. Herbal materials may
contain microbiological contaminants. During harvesting and
processing, herbal products that are prone to microbial contamination
are produced. To avoid alterations and reduce contamination, a high
level of sanitation and hygiene is necessary during the manufacturing
process. Waste from the manufacturing unit should be disposed of
regularly to maintain a high standard of hygiene in the manufacturing
area. Waste bins should be available, emptied, and cleaned at least daily.
(c) Medical Services:
Annual medical check-ups of all employees should be done to ensure
freedom from infectious diseases. The first aid facility should be
available and the health records of all the employees should be
maintained.
(d) Machinery and Equipment:
Equipment should be according to the size of the operation and the
nature of the product manufactured. Semi-automatic or automatic
machines should be available in the manufacturing unit such as;
crushing, grinding, powdering, boiling, mashing, burning, roasting,
filtering, drying, filling, labeling packing, etc. To ensure comfort in the
movement of workers adequate space should be ensured between two
machines or rows of machines. This equipment has to be properly
installed and maintained with proper cleaning. Proper Standard
Operational Procedures (SOPs) for cleaning, maintaining, and
performing of every machine should be maintained.
(I) Batch Manufacturing Records:
It includes records of raw materials used, the quantity obtained from the
store, and tests conducted during the various stages of manufacture like;
taste, color, physical characteristics and chemical tests. All
manufacturing records should be duly signed by production and quality
control personnel respectively. It is essential to maintain the record of
the date, manpower, machine, and equipment used along with the in-
process record of various Shodhana (purification procedures of
poisonous drugs), and trituration in terms of internal use.
(m) Distribution records:
Records of sale and distribution of each batch of Ayurveda, Siddha and
Unani drugs should be maintained to facilitate quick and complete batch
recall when needed.
(n)Record of market complaints:
Manufacturers should maintain a register to record the complaints and
corrective action initiated to prevent repetition regarding the products.
Once in six months, the complaint records must be sent to the licensing
authority. A register should be available for inspection during any
inspection of the premises. Reports of any adverse reaction resulting
from the use of drugs should be maintained in a separate register.
(o) Quality Control:
Every licensee is required to provide a facility for quality control section
in his own premises or Government approved testing laboratory. The test
should be as per the Ayurveda, Siddha and Unani Pharmacopoeia
standard. There should be 150 sq. feet area for quality control section.
The manufacturing record should be maintained for the various
processes. The finished products, controlled samples of finished
products of each batch should be kept for 3 years. The standards for
identity, purity and strength as given in respective pharmacopoeias of
Ayurveda, Siddha and Unani systems of medicines published by
Government of India should be maintained. All the raw materials should
be monitored for virus, fungal and bacterial contamination with a view
to minimize such contamination. Quality control section should have
one person with Degree qualification in Ayurveda/Siddha/Unani
(A.S.U.) as per Schedule n of Indian Medicine Central Council Act 1970
(84 of 1970) of a recognized university or board. A person with a
Bachelor of Pharmacy, Pharmacognosy, and Chemistry can accompany
the quality control section.
(p)Requirement of Sterile Product:
A separate enclosed area should be provided for the manufacturing area
to produce sterile Ayurvedic products. This area should be aseptic, dust-
free, moisture-free, and have a bacteria-free air supply.
GOOD LABORATORY PRACTICE (GLP)
Good Laboratory Practice (GLP) is a quality system concerned with the
organizational process and the conditions, under which non-clinical
health and environmental safety studies are planned, performed,
monitored, recorded, archived and reported. Good Laboratory ractice
(GLP) regulations became part of the regulatory bodies in the latter part
of the 1970s in response to malpractice in research and development
(R&D) activities by pharmaceutical companies and contract facilities
used by them. In 1981, the Organization for Economic Cooperation and
Development (OECD) also published GLP Principles and these now
dominate the international arena. To date 30 countries (the member
states of the OECD) have signed an agreement binding them to OECD
GLP Principles. Other non-OECD member states have also adopted the
OECD GLP Principles.
Objectives of GLP:
 GLP is to certify that every step of the analysis is valid or Not.
 Assure the quality and integrity of data submitted to FDA in
support of the safety of regulated products.
 GLPs have a heavy emphasis on data recording, record and
specimen retention.
General Requirements to establish GLP for medicinal plants:
(a) Test Facility Organization and Personnel:
 Test Facility Organization and Personnel should have
knowledge of the GLP principles.
 Approve the study plan and appropriate SOP's. Any
modifications to the study plan should be documented and
recorded by dated Signature.
 Availability of SOPs to the personnel.
 Raw data generated are to be fully documented and
recorded.
 Study personnel are responsible for the quality of their data.
 Implementation of health precautions to minimize risk.
 Computerized systems used in the study should be
validated.
 Ensure that after completion of the study, the study plan, the
final report, raw data and supporting material are archived.
(b)Quality Assurance Program:
  Quality assurance personnel should have access to the
updated study plans and SOP's. The study plan contains
information and verification.
 Conduct inspections to determine compliance of the study
with GLP principles. There are three types of inspection-
Study-based inspections, facility-based inspections and
process-based inspections.
 Records of such inspections should be retained arod
reported to the management.
(c) Facilities:
 Test system facilities: A sufficient number of rooms assures
the isolation of test systems and the isolation of individual
projects involving substances or organisms known to be or
suspected of being biohazardous. There should be storage
rooms or areas as needed for supplies and equipment. Areas
should be available to diagnose, treat, and control diseases,
to ensure no unacceptable degree of deterioration of test
systems.
 Archive Facilities: Archive facilities should be provided for
the secure storage and recovery of study plans, raw data,
final reports, samples of test items and specimens. Archive
design and archive conditions should protect contents from
early deterioration.
 Waste disposal: Handling and disposal of wastes should be
done so as not to risk the integrity of studies. This includes;
facility for the appropriate collection, storage and disposal,
decontamination and transportation procedures.
(d)Apparatus, Material and Reagents:
Apparatus used in the study of medicinal plants should be
periodically inspected, cleaned, maintained and calibrated
according to Standard Operating Procedures (SOPs). Apparatus
and materials used in the study should not interfere with the test
systems. Chemicals, reagents and solutions should be labelled to
indicate identity (with concentration), expiry date and specific
storage instructions. Information concerning the source,
preparation date and stability should be available. The expiry date
may be extended on the basis of documented evaluation or
analysis.
(e) Test Systems and Reference Items:
 Test systems include; physical, chemical and biological test
systems. Records of source date of arrival and arrival conditions of
test systems should be maintained and documented. Proper
identification of test systems in their container or when removed,
cleaning and sanitization of containers and pest control agents to
be documented. Receipt. handling, sampling, storage, stability of
the test item in its vehicle and samples for analytical purposes for
each batch should be maintained and documented.
(f) Standard Operating Procedures (SOP):
A written procedure for a laboratory program is often written in
chronological order of their action steps. They are written to
explain how the procedures are supposed to work like; routine
inspection, cleaning, maintenance, testing, calibration, actions to
be taken in response to equipment failure, keeping records,
reporting, storage, mixing, recovery of data and analytical
methods.
(g) Performance of the Study:
Performance of the study includes; preparing the study plan, the
content of the study plan and identification of the study. It also
includes; records, dates, references to test methods, information
concerning the sponsor and facility, and the conduct of the study.
(h)Reporting, of Study Results:
• It includes information on the sponsor and test facility.
• Starting and completion dates of the experiment.
• Quality assurance program statement.
• Description of materials and test methods.
• Results.
• Storage (samples, reference items, raw data, final report,
etc.).
(i) Storage, Retention of Records and Materials:
• It comprises the study plan, raw data, and samples.
• Inspection data and master schedules.
• SOPs.
• Maintenance and calibration of the data.
• If any study material is disposed of before expiry the reason
is to be justified and documented.
• Index of materials retained.
WHO GUIDELINES ON CURRENT GOOD
MANUFACTURING PRACTICE (cGMP) FOR HERBAL
MEDICINES
The World Health Assembly requested WHO to provide technical
support to develop a methodology to monitor or ensure the quality,
efficacy, and safety of traditional medicine and its products. The
quality of herbal medicines can directly affect their safety and
efficacy. Member States handled complicated technical issues in the
quality control of herbal medicines. To promote and improve the
quality of herbal medicines and also to reduce the proportion of
adverse effects caused by the poor quality of herbal medicines. WHO
has committed to the development of guidelines related to quality
assurance and control of herbal medicines, as well as to update
existing guidelines. The manufacturing process is one of the key steps
where quality control is required to ensure the quality of medicinal
products including; herbal medicines. cGMP is one of the most
important tools for this measure.
WHO Guidelines on Current Good Manufacturing Practices:
(a) Quality assurance in the manufacture of herbal medicines:
The use of modern analytical techniques especially; high-performance
thin layer chromatography (HPTLQ, gas chromatography (GQ, high-
performance liquid chromatography (HPLC), capillary
electrophoresis (CE), mass spectrometry (MS) and atomic absorption
(AA) are used to characterize herbal medicines. Quality assurance
also requires the control of starting materials, storage and processing.
For this reason, an appropriate quality assurance system should be
applied in the manufacture of herbal medicines.
(b) Sanitation and hygiene: Herbal materials may contain
microbiological contaminants. During the course of harvesting and
processing, herbal products that are prone to microbial contamination
are produced. To avoid alterations and reduce contamination, a high
level of sanitation and hygiene is necessary during the manufacturing
process. Water supply to the manufacturing unit should be monitored
and if necessary, treated appropriately to ensure consistency of
quality.
Waste from the manufacturing unit should be disposed of regularly so
as to maintain a high standard of hygiene in the manufacturing area.
Waste bins should be available, emptied, and cleaned at least daily.
(c) Qualification and validation: Qualification of critical equipment,
process validation, and change control are important in the production
of herbal medicines with unknown therapeutically active constituents.
In this case, the reproducibility of the production process is the main
means for ensuring consistency of quality, efficacy, and safety
between batches.
The written procedure should specify process steps and factors (such
as; extraction time, temperature, and solvent purity), acceptance
criteria the type of validation to be conducted and the number of
process runs.
A formal change control system should be established to evaluate the
potential effects of changes on the quality of the herbal medicines,
mostly the content of the active ingredients. Scientific judgment
should be used to determine which additional testing and validation
studies are appropriate to justify a change in a validated process.
(d) Complaints: The person responsible for handling complaints and
deciding on the measures to be taken to deal with them should have
appropriate training and/or experience in the specific features of the
quality control of herbal medicines. There are two types of
complaints; product quality complaints and adverse reactions/events.
Product quality complaints may be caused by problems such as; faulty
manufacture, product defects or deterioration of herbal medicines, and
adulteration of the herbal material. These complaints should be
recorded in detail and their causes by comparing them with the
reference samples kept from the same batch. There should also be
written procedures to describe the action to be taken.
Adverse reactions complaints, and reports of any adverse
reaction/event should be entered in a separate register per 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. In either
case, complaint records should be reviewed regularly to detect any
specific or recurring problems requiring special attention and possible
recall of marketed products.
(e) Product recalls: The product recall procedure depends on national
regulations. There should be a standard operating procedure (SOP) for
the storage of recalled herbal medicines in a secure isolated area,
complying with the requirements specified.
(f) Contract production and analysis: The contract partner should
have adequate premises and equipment for the production of herbal
medicines according to GMP. Validated methods should be applied
for cleaning the equipment and premises carefully before using them
to produce different herbal medicinal, food, or cosmetic products.
Technical aspects of the contract should be drawn up by experienced
people suitably knowledgeable on the specific characteristics of
herbal medicines including; their production and quality control
testing.
(g) Self-inspection: One member of the self-inspection team should
have a thorough knowledge of herbal medicines.
(h) Personnel: The manufacturer should have an adequate number of
personnel with the required qualifications and practical experience.
All responsible staff should have their duties recorded in written
descriptions and adequate authority to carry out their responsibilities.
Their duties may be given to designated deputies of a satisfactory
qualification level. There should be no gaps or unexplained overlaps
in the responsibilities of the personnel concerned with the application
of cGMP. The manufacturer should have an organization chart. All the
personnel should be aware of the principles of cGMP 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. Steps
should be taken to prevent unauthorized people from entering
production, storage, and quality control areas. Personnel who do not
work in these areas should not use them as a passageway.
(i) Training: The personnel should have adequate training in
appropriate fields such as; pharmaceutical technology, taxonomic
botany, phytochemistry, pharmacognosy, hygiene, microbiology, and
related subjects (such as; traditional use of herbal medicines).
Training records should be maintained and periodic assessments of
the effectiveness of training programs should be made.
(j) Personal hygiene: Personnel assigned with the handling of herbal
materials, herbal preparations, and finished herbal products should
have a high degree of personal hygiene and have received adequate
training in maintaining appropriate standards of hygiene. The
personnel should not work if they have infectious diseases or skin
diseases. Written procedures listing the basic hygiene requirements
should be made available. Personnel must be protected from contact
with toxic irritants and allergenic plant materials using suitable
protective clothing. They should wear suitable gloves, caps, masks,
work suits, and shoes throughout the whole procedure from plant
processing to product manufacture.
(k) Premises: The premises should be designed, located, constructed,
adapted, and maintained to suit the operations to be carried out
according to WHO guidelines. Because of their possibility for
degradation, infestation with certain pests, and sensitivity to
microbiological contamination, the production, and storage of herbal
materials and herbal preparations need special importance.
(I) Storage areas: Storage areas should be well organized and tidy.
Special attention should be paid to cleanliness and good maintenance.
Any accidental spillage should be cleaned up immediately using
methods that minimize the risk of cross-contamination of other
materials. and should be reported. The set-up of storage areas depends
on the type of materials stored. The areas should be well labelled and
materials stored in such a way as to avoid any risk of cross-
contamination. An area should be identified for the quarantine of all
incoming herbal materials. Different herbal materials should be stored
in separate areas. To protect the stored material, and reduce the risk of
pest attacks, the duration of storage of herbal material in unpacked
form should be kept to a minimum. Incoming fresh herbal materials
should be processed, Otherwise, they should be stored between 2ᵒC
and 8ᵒC whereas, frozen materials should be stored below -18ᵒC. Bulk
materials are advisable to store in aerate rooms or containers using
natural or mechanical aeration and ventilation. These areas should
also be equipped in such a way as to protect against the entry of
insects or animals, especially rodents. Effective measures should be
taken to limit the spread of animals and microorganisms brought in
 with the plant material and to prevent crosscontamination. Plants,
extracts, tinctures, and other preparations require special conditions of
humidity and temperature or protection from light. Steps should be
taken to ensure that these conditions are provided, maintained,
monitored, and recorded.
(m) Production areas: The production areas of herbal medicines
require that more attention should be given to processing products
that generate dust. When heating or boiling of the materials is
necessary, a suitable air exhaust mechanism should be employed to
prevent the accumulation of fumes and vapors. To facilitate cleaning
and to avoid crosscontamination, adequate precautions should be
taken during the sampling. weighing. mixing and processing of
medicinal plants, e.g. by use of dust extraction and air-handling
systems to achieve the desired pressure and net airflow.
(n) Equipment: Processing of herbal materials may generate dust or
material which is susceptible to pest infestation or microbiological
contamination and cross-contamination. Effective cleaning of the
equipment is therefore necessary. Vacuum or wet-cleaning methods
are preferred. If wet-cleaning is done, the equipment should be dried
immediately after cleaning to prevent the growth of micro-organisms.
Cleaning with compressed air and brushes should be done with care
as these methods increase the risk of product contamination.
(o) Materials: All incoming herbal materials should be quarantined
and stored under appropriate conditions. Only permitted substances
should be used for fumigation and allowable limits for their residues
together with specifications for the apparatus used should be set
according to the national regulations.
The reference standard for herbal medicine is a botanical sample of
the herbal material. A sample of the herbal preparation can be an
extract a known active constituent a marker substance or a known
impurity. If the herbal medicine is not described in a recognized
pharmacopoeia, a herbarium sample of the flowering or fruiting top of
the whole medicinal plant or part of the medicinal plant should be
available. All reference standards should be stored under appropriate
conditions to prevent degradation. Their expiry and/or revalidation
date should be determined and indicated.
(p)Documentation:
 The family and botanical name of the plant are used according
to the binomial system (genus. species. variety and the
authority, i.e. the reference to the originator of the
classification, e.g. Linnaeus). It may also be appropriate to add
the vernacular name and the therapeutic use in the country or
region of origin of the plant.
 Details of the source of the plant such as; country and region
of origin whether it was cultivated or collected from the wild
and, where applicable, method of cultivation, dates and
conditions of harvesting, collection procedures, collection area
and brand, quantity and date of pesticide application, as
required by the WHO Guideline.
 Whether the whole plant or only a part is used. For dried plant
material, the drying system should be specified, if applicable.
 A description of the plant material based on visual
(macroscopic) and/or microscopic examination should be
available.
 Suitable identity tests including identification tests (such as;
TLC or other chromatographic fingerprints) for known active
ingredients or markers. A reference sample should be available
for identification purposes.
 Details of the assay of active constituents or markers.
 Limit tests such as; dry residue of liquids, ash value (total ash
and ash insoluble in hydrochloric acid), water-soluble
extractive value, moisture/water content and loss on drying.
 Suitable methods for the determination of possible pesticide
contamination and the acceptable limits for such
contamination in herbal materials or herbal preparations used
in the manufacture of herbal medicines.
 Tests for toxic metals and for likely contaminants, foreign
materials, and adulterants.
 Tests for fungal and/or microbiological contamination,
fumigant residues, mycotoxins, pest infestations, radioactivity,
and their acceptable limits.
 Particle size, swelling index, and residual solvents in herbal
preparations and biological fingerprints such as; induced
fluorescent markers.
 Specifications for starting materials if applicable, reference to
a pharmacopoeia! monograph should be included.
 If the herbal material for processing does not comply with its
quality specifications, the rules that apply for its rejection,
storage and disposal of the rejected herbal material should be
included.
 Starting materials derived from genetically modified
organisms should comply with existing national or
international regulations and the label should include this
information. Chemical protection of herbal materials should be
in accordance with national and/or international regulations.
 Uniformity of weight, disintegration time (for tablets, capsules,
suppositories, and pills), hardness and friability (for uncoated
tablets), viscosity (for internal and external fluids), consistency
(semi-solid preparations) and dissolution (tablets or capsules),
if applicable should be included.
 Physical appearance such as; colour, odour, form, shape, size
and texture.
 The control tests and the finished herbal product should allow
the qualitative and quantitative determination of the main
active constituents. If the therapeutic activity of constituents is
known, these constituents should be indicated in the
documentation. If such substances are not known, the
constituents useful for assessing the quality should be
identified as markers. In both cases, the assay specifications
should be defined. When the therapeutic activity of the
constituents cannot be determined quantitatively, specifications
should be based on the determination of markers.
 If either the final product or the herbal preparation contains
several herbal materials and a quantitative determination of
each active ingredient is not feasible, the mixture of several
active ingredients may be determined. The need for such a
procedure should be justified.
 The concept of shelf life specifications applies to finished
herbal medicines only and not to herbal materials and herbal
preparations.
 The processing instructions should describe the different
operations to be performed on the plant material such as;
drying, crushing, milling and sifting. They should also include;
the time, temperatures required in the drying process and the
methods to be used to control fragment or particle size.
 Instructions on removing foreign matter and other unwanted
materials should also be given.
 The drying conditions chosen should be appropriate to the type
of plant material processed. These depend on both the
character of the active ingredients like; essential oils and the
type of plant part collected (root. leaf or flower). Drying by
direct exposure to sunlight is possible, but drying on the
ground should be avoided. If the plant parts are processed
fresh, without drying, the reasons and criteria determining the
use of fresh material should be stated.
 For the production of processed extracts, the instructions
should specify details of any vehicle or solvent that may be
used, the duration and temperature needed for extraction,
concentration stages and methods that may be required.
 The permissible environmental conditions e.g. temperature,
humidity and standard of cleanliness, should be stated.
 Steps in the processes of blending and adjustment to reach
defined contents of pharmacologically active constituents
should be documented.

(q)Good production practices:

• Medicinal plants that are either cultivated or collected
from the wild source and which may be used in crude
form or subjected to simple processing techniques
(cutting or comminuting), the first critical step of their
production, i.e. where the application of these guidelines
starts, should be designated. The rationale for this
designation should be stated and documented. However,
for processes such as; extraction, fermentation, and
purification, this rationale should be established
individually.
• Collection/cultivation and harvesting of medicinal plants
should follow guidance such as; the WHO Guideline on
Good Agriculture and Collection Practices (GACP) for
medicinal plants or a national guideline.
• When the active ingredient consists of comminuted or
powdered herbs, application of these guidelines starts at
the physical processing following primary cutting and
comminuting and also includes packaging.
• When herbal extracts are used, these guidelines should
apply to any production step following post-harvest
processing.
• In the case of finished herbal products manufactured by
fermentation, the application of cGMP should cover the
production step following primary cutting and
comminuting. Attention should be given to the
introduction of cells from a cell bank into the
fermentation process.
• Materials should be handled carefully so that, it is not
harmful to the product. On arrival at the processing
facility, the herbal material should be promptly unloaded
and unpacked. During this operation, the herbal material
should not come into direct contact with the soil.
Moreover, it should not be exposed directly to the sun
{except in cases of sun-drying drugs) and it should be
protected from rain and microbiological contamination.
• Attention should be paid to "classification· of clean area
requirements taking into account the possible high degree
of initial microbial contamination of herbal materials.
Specific and detailed requirements should be developed
to cover microbial contamination of equipment, air,
surfaces, and personnel and also for restrooms, and
utilities. ancillary and supporting systems {e.g. water and
compressed air).
• Care should be taken to choose cleaning methods
appropriate to the characteristics of the herbal materials
being processed. Washing dried herbal materials with
water is inappropriate. When it is necessary to clean them,
an air duster or air shower should be employed.
• The presence of plant materials from different species and
varieties or different plant parts should be controlled
during the entire production process to avoid
contamination unless it is assumed that these materials are
equivalent.
• If time limits are specified in the master production
instructions, these limits should not be exceeded, to
ensure the quality of intermediates and finished products.
 • Herbal medicines with constituents of known therapeutic
activity are often standardized. The methods used to
achieve such standardization should be documented. If
another substance is added for these purposes, it is
necessary to specify the range and the quantity that may
be added. Blending different batches of a specific herbal
material (before extraction) or by mixing different lots of
similar herbal preparations may also be acceptable.
Records should be maintained to ensure traceability. The
blending process should be adequately controlled and
documented.
• Batches should be mixed only if it can be guaranteed that
the mixture will be homogeneous. Such processes should
be well documented.
• Blending operations should be validated to show the
uniformity of the combined batch. Validation should
include testing of critical attributes {particle size
distribution, bulk density, and tap density).
• The expiry date of the blended batch should be chosen
according to the date of manufacture of the oldest batch in
the blend.
(r) 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, recognize adulteration, the presence of
fungal growth or infestations, and lack of uniformity in the
delivery of herbal materials.
 The quality control of the herbal material, herbal preparations,
and finished herbal products should establish their quality but
does not indicate the control of every single constituent.
 Herbal materials are a collection of individual plants and/or
different parts of the same plant and thus, have an element of
heterogeneity. Sampling should be carried out with special
care by personnel with the necessary expertise.
 The identity and quality of herbal material, herbal
preparations, and finished herbal products should be tested.
 Identification tests may be based on - physical, macroscopic
(organoleptic), and microscopic tests, chromatographic
procedures (TLC, HPLC, HPTLC or gas-liquid
chromatography (GLC), spectrometric techniques (ultraviolet-
 visible,), IR, nuclear magnetic resonance (NMR), MS, and/or
chemical reactions.
 The identification test methods should be specific for the
herbal material, herbal preparation, or finished herbal product
and ideally should be capable of discriminating between the
required herbal material and potential substitutes or adulterants
that are likely to occur.
 Reference samples of herbal materials should be made
available for use in comparative tests, e.g. visual and
microscopic examination and chromatography.
 Quantitative determination of known active components and
marker compounds is necessary.
 The development and execution of quality control methods for
herbal materials, herbal preparations, and finished herbal
products should be in line.
 For finished herbal products containing herbal materials,
fingerprint chromatograms may be applicable. Using these
methods, it may ensure that the main constituents can be easily
followed throughout the production process. Caution is
necessary, however, for every delivery of herbal materials and
every batch of herbal preparations (including extracts) will
have slightly different chromatograms/fingerprints resulting
from differences in chemical compositions caused by intrinsic
or extrinsic factors.
 If the expiry date for herbal material or herbal preparation is
given, some stability data to support the proposed shelf life
under the specified storage conditions should be available.
Stability data are always required to support the shelf-life
proposed for the finished herbal products.
 Finished herbal products may contain several herbal materials
or herbal preparations, and it is often not feasible to determine
the stability of each active ingredient. Chromatography allows
the tracing of changes that may occur during the storage of a
complex mixture of biologically active substances contained in
herbal materials. The fingerprint methods used for the stability
studies should be as similar as possible to those used for
quality control purposes.
 The stability of preservatives and stabilizers should be
monitored. When these are not used, alternative tests should be
 done to ensure that the product is self-preserving over its shelf
life.
 Samples used for stability studies should be stored in the
containers intended for marketing.
 The protocol for ongoing stability studies should be
documented. This would normally involve one batch per year
included in a stability-monitoring program.
 All packaging materials such as; bottles and other materials
should be stored properly. Controls on the issue and use of
these packaging materials should be adequate to ensure that
incorrect labels and cartons are not used.
 All the containers and closures should be thoroughly cleaned
and dried before being used to pack the products.
 There should be adequate information on the label (or the
package insert) to inform the users of the composition of the
product (in addition to the brand name), indications or actions,
directions for use, cautions, adverse reactions if any, and the
expiry date.
 Finished herbal products may contain several herbal materials
and/or herbal preparations. The full quantitative composition
of the herbal ingredients should be stated on the product label.
If this is not possible, at least the main ingredients should be
stated on the label while, the full qualitative composition could
appear on the package insert.
 The composition of any solvent or solvent mixture used and
the physical state of the extract should be identified.
 If any other substance is added during the manufacture of the
herbal preparation to adjust the level of constituents of known
therapeutic activity, or for any other purpose, the added
substance(s) should be described as such or as "other
ingredients" and the genuine extract as the ·active ingredient".
However, where different batches of the same extract are used
to adjust constituents with known therapeutic activity to a
defined content or for any other purpose, the final mixture
should be regarded as the genuine extract and listed as the
"active ingredient" in the unit formula.

WHO GUIDELINES ON GOOD AGRICULTURAL AND

COLLECTION PRACTICES (GACP) FOR MEDICINAL
PLANTS
The WHO guidelines on good agricultural and collection
practices (GACP) for medicinal plants are mainly intended to
provide general technical guidance on obtaining medicinal
plant materials of good quality for the sustainable production
of herbal products classified as medicines. Raw medicinal
plant materials should meet all applicable national and/or
regional quality standards. The guidelines should be adjusted
according to each country's situation.
The main objectives of GACP guidelines are:
a) To contribute to the quality assurance of medicinal plant
materials used as sources.
b) (b)Herbal medicines: This aims to improve the quality,
safety, and efficacy of finished herbal products.
c) To guide the formulation of national and/or regional GACP
guidelines and GACP monographs for medicinal plants and
related standard operating procedures.
d) To encourage and support the sustainable cultivation and
collection of medicinal plants of good quality and support
the conservation of medicinal plants and the environment.
The WHO Guidelines on Good Agricultural and
Collection Practices (GACP) for Medicinal Plants is
divided into two sections:
Section A (Good Agricultural Practices for Medicinal
Plants) and Section B (Good Collection Practices for
Medicinal Plants).
Section A: Good Agricultural Practices (GAP) for
medicinal plants:
The Good Agricultural Practices (GAP) for medicinal
plants is the same as the General guidelines on GAP for
medicinal plants.
Section B: Good Collection Practices (GCP) for
Medicinal Plants:
This section describes the general and basic methods for
small and large-scale collection of fresh medicinal plant
materials. Collection practices should confirm the long-
term survival of wild populations and their associated
habitats. Management plans for collection should provide a
framework for setting sustainable harvest levels and
describe appropriate collection practices that are suitable
for each medicinal plant species and plant part used (roots,
leaves, fruits, etc.). The collection of medicinal plants raises
several complex environmental and social issues that vary
widely from region to region. These issues must be
addressed locally on a case-by-case basis.
(a) Permission to collect: In some countries, collection
permits and other documents from government authorities
and landowners must be obtained prior to collecting any
plants from the wild. Sufficient time for the processing and
issuance of these permits must be allocated at the planning
stage. National legislation such as; national ·red" lists,
should be consulted and respected.
For medicinal plant materials intended for export from the
country of collection, export permits, phytosanitary
certificates, Convention on International Trade in
Endangered Species of Wild Fauna and Flora (CITES)
permit(s) (for export and import), CITES certificates (for
re· export) and other permits must be obtained, when
required.
(b) Technical planning: Before initiating a collection
expedition, the geographical distribution and population
density of the target medicinal plant species should be
determined. Distance from home base and quality of the
target plant(s) available are factors to be considered. When
the collection sites have been identified, local and/or
national collection permits should be obtained.
All the information on the target species (taxonomy,
distribution, phenology, genetic diversity, reproductive
biology, and ethnobotany) should be obtained. Data about
environmental conditions including; topography, geology,
soil, climate, and vegetation at the prospective collecting
site(s), should be organized and presented in a collection
management plan.
Research on the morphology of the target medicinal plant
species and the variability of its populations should be
carried out to develop a "search image· for the species.
Copies of photographs of the target medicinal plant(s) from
books and herbarium specimens and ethnographical
information (common or local names) of the target species
and plant parts are useful field instruments, especially for
untrained workers. Botanical keys and other taxonomic
 identification aids are useful at collection sites where, either
related species or unrelated species of similar
morphological characteristics may be found.
Rapid, safe, and dependable transportation to carry
personnel, equipment, supplies, and collected medicinal
plant materials should be arranged in advance.
A collection team familiar with good collecting techniques,
transport, and handling of equipment and medicinal plant
materials including; cleaning, drying, and storage, should
be assembled. Training of personnel should be conducted
regularly. All the investors, manufacturers, traders, and
government are accountable for the conservation and
management of the targeted medicinal plant species. The
responsibilities of all those involved in the collection
should be set out in a written document.
The social impact of field collection on local communities
should be examined and the ecological impact of field
collection activities should be monitored over time.
(c) Selection of medicinal plants for collection:
• The species or botanical variety selected for collection
should be the same as that specified in the national
pharmacopoeia or recommended by other authoritative
national documents of the end-users country, as the source
for the herbal medicines concerned.
• In the absence of such national documents, the selection
of species or botanical varieties specified in the
pharmacopoeia or other authoritative documents of other
countries should be considered.
• In the case of newly introduced medicinal plants, the
species or botanical variety selected for collection should
be identified and documented as the source material used
or described in traditional medicine in the original
countries.
• Collectors of medicinal plants and producers of medicinal
plant materials and herbal medicines should prepare
botanical specimens for submission to regional or
national herbaria for authentication. The voucher
specimens should be retained for a sufficient time and
should be preserved under proper conditions. The name of
the botanist or other experts who provided the botanical
 identification or authentication should be recorded. If the
medicinal plant is not well known to the community, then
documentation of the botanical identity should be
recorded and maintained.
(d)Collection:
• Collection practices should ensure the long-term survival
of wild populations and their associated habitats. The
population density of the target species at the collection
site(s) should be determined and rare species should not
be collected.
• To encourage the regeneration of source medicinal plant
materials, the demographic structure of the population has
to be ensured. Management plans should refer to the
species and the plant parts (roots. leaves, fruits, etc.) to be
collected and should specify collection levels and
collection practices. It is mandatory to the government or
environmental authority to ensure that buyers of collected
plant material do not place the collected species at risk.
• Medicinal plant materials should be collected during the
appropriate season or period to ensure the best possible
quality of both source materials and finished products. It
is well known that the quantitative concentration of
biologically active constituents varies with the stage of
plant growth and development. This also applies to non-
targeted toxic or poisonous indigenous plant ingredients.
The best time for collection (quality peak season or time
of day) should be determined according to the quality and
quantity of biologically active constituents rather than the
total vegetative yield of the targeted medicinal plant parts.
• Only ecologically non-destructive systems of collection
should be employed. These will vary widely from species
to species. For example, when collecting roots of trees
and bushes, the main roots should not be cut or dug up,
and cutting off the taproot of trees and bushes should be
avoided. Only some of the lateral roots should be located
and collected.
• When collecting species whose bark is the primary
material to be used, the tree should not be girdled or
completely stripped of its bark; longitudinal strips of bark
along one side of the tree should be cut and collected.
• Medicinal plants should not be collected in or near areas
where, high levels of pesticides or other possible
contaminants are used or found, such as roadsides,
drainage ditches, mine tailings, garbage dumps, and
industrial facilities which may produce toxic emissions.
Also, the collection of medicinal plants in and around
active pastures, including; riverbanks downstream from
pastures, should be avoided to avoid microbial
contamination from animal waste.
• During the process of collection, efforts should be made
to remove parts of the plant that are not required and
foreign matter, in particular toxic weeds. Decomposed
medicinal plant materials should be discarded.
• The collected raw medicinal plant materials should not
come into direct contact with the soil. If underground
parts (such as; the roots) are used. Any adhering soil
should be removed from the plants as soon as they are
collected. Collected material should be placed in clean
baskets, mesh bags, or other well-aerated containers that
are free from foreign matter, including plant remnants
from previous collecting activities.
• After collection, the raw medicinal plant materials may be
subjected to preliminary processing including; the
elimination of undesirable materials and contaminants,
washing (to remove excess soil), sorting, and cutting.
• The collected medicinal plant materials should be
protected from insects, rodents, birds, and other pests, and
livestock and domestic animals.
• If the collection site is located some distance from
processing facilities, it may be necessary to air or sundry
the raw medicinal plant materials before transport.
• If more than one medicinal plant part is to be collected,
the different plant species or plant materials should be
gathered separately and transported in separate
containers. Cross-contamination should be avoided at all
times.
(e) Personnel:
• Local experts responsible for the field collection should
have formal or informal practical education and training
 in plant sciences and have practical experience in the
fieldwork. They should be responsible for training any
collectors who lack the technical knowledge to perform
the various tasks involved in the plant collection process.
• They are also responsible for the supervision of workers
and the full documentation of the work performed. Field
personnel should have adequate botanical training and
should be able to recognize medicinal plants by their
common names and ideally, by their scientific (Latin)
names.
• Local experts should serve as knowledgeable links
between non-local people, local communities, and
collectors. All collectors and local workers involved in
the collection operation should have sufficient knowledge
of the species targeted for collection and be able to
distinguish target species from botanically related and/or
morphologically similar species.
• Collectors should also receive instructions on all issues
relevant to the protection of the environment and the
conservation of plant species, as well as the social
benefits of sustainable collection of medicinal plants.
• The collection team should take measures to ensure the
welfare and safety of staff and local communities during
all stages of medicinal plant sourcing and trade. All
personnel must be protected from toxic and dermatitis-
causing plants, poisonous animals and disease-carrying
insects. Suitable protective clothing including; gloves,
should be worn when necessary.