QUALITY ASSURANCE IN HERBAL DRUG INDUSTRY

INTRODUCTION

 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 compile a well structured, comprehensive documentation on pharmaceutical
development and testing.
 The producers should make continued efforts to improve standards.
 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 of 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 enforced by

the FDA.
 It 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.
 It helps to prevent contamination, mix-ups, deviations, failures and errors. Thus,
assures that drug products meet the Current Good Manufacturing Practice
regulations.
 Highly trained FDA staffs inspect pharmaceutical manufacturing facilities
worldwide including: facilities that manufacture active ingredients and the
finished product.
 If a company is found not complying with cGMP regulations, any drug it makes is
considered "adulterated" under the law.

Objectives of cGMP

(a) cGMP regulations assure that quality is built into the design and manufacturing
process at every step.
(b) Manufacturing facilities are in good condition.
(c) Equipments are properly maintained and calibrated.
(d) Employees are qualified and fully trained.
(e) 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:

Fig: 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 evaluation of returned and
salvaged drug products.

(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
provide a proper physical environment and resources used in the production of the
drugs or drug products. It includes:

 Buildings and facilities along with maintenance.

 Equipment qualifications (installation and operation).
 Equipment calibration and preventative maintenance.
 Cleaning and validation of cleaning processes.

Utilities that are not intended to be incorporated into the product such as; 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 in terms of both the quality and quantity of any crop
intended for health purposes.
 The guidelines on Good Agricultural Practices (GAP) provide us the documented
proof on how to handle medicinal plants right from its cultivation to post-
harvesting operations.
 GAP are the basic environmental and operational conditions necessary for the
production of safe, wholesome fruits and vegetables

Objectives of GAP:

(a)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.

(b)To guide the formulation of national or regional guidelines and monographs for
medicinal plants and related standard operating procedures (SOPs).

(c)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.

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 o 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
us 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

(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.
 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.

(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 past 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.
 The social impact of cultivation on local communities 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.

(h) 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.
 Daytime and nighttime temperature differences, also influence the physiological
and biochemical activities of plants.

(i)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 Yield of medicinal plants
(j) 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 growth.
 Water used for irrigation purposes should comply with local, regional and nation
quality standards.
 Care should be exercised to ensure that the plants under cultivation a neither over
nor under-watered.

(k) 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 pesticide and herbicides should be applied at the
minimum effective level .
 All applications should be documented.

(l) Harvesting and Drying:

 Medicinal plants should be harvested during the optima 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.
 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.
 A containers used, should be kept clean and free from contamination by previously
harvested medicinal plants and other foreign matter.
 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.

(m) 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 than-20°C2.6.

(n) 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 person 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 commercial sources. As a result of 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. GMP is that 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 as
adulterated if GMPs are not met. GMP standards are the only guidelines alternative
process and control mechanisms that can be used as an essential tool to assure quality.

Objevtives of GMP

 Raw materials used in the manufacture of drugs are authentic of prescribed quality
and are 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 from sale is of acceptable quality.

General Requirements to establish GMP for medicinal plants;

1.Location and Buildings

 No open sewage.

 No drainage coming from public areaslavatory.

 No factory fumes.
 No excessive soot, Smoke and dust.

2.buildings

 buildings should be in hygienic condition.

 No cobwebs/insects/rodents.

 Sufficient slight, ventilation and working space.

 No dampness or moisture Should be THERE on the floor and walls.

 Wall and floors should be even.

 Proper placement of equipment’s to avoid risk of mixing and cross contamination.

 Designed, constructed and maintained well to prevent the entry of insects and
rodents

 The interior surface should be smooth, and even so us note permit retention or
accumulation of dust or waste product.

3.proper drainage system

 Sanitary fittings and electrical fixtures Should be used for safety.

 Furnace section should be covered with a tin roof.

 Proper ventilation/chimney in the factory

 Proper fire safety measures /exits should be installed.

4.Water supply

The water used in manufacturing should be pure or portable quality. An adequate

supply of water is required for washing the premises and containers.

5.Disposal of waste

In the manufacturing section and laboratories, the waste water And residues are
disposed of suitable treatment as per the guidelines Of pollution control to be
followed.
6. Containers cleaning

Adequate arrangements for washing, cleaning and ring of containers should be there.

7.Stores

There Should be sufficient space 4 stores of different types of material such as raw
materials packaging materials Andy finished products. Do store should have proper
ventilation and should be free from dampness.

1. Raw materials stores: Should have adequate containers which 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, plant parts, volatile oils etc.Each container of raw materials should be
identified with proper label which indicate the name of the raw material, source of
supply and should also clearly state the status of raw material such as under test or
approved or rejected.

2. Packing material stores: All packing materials such as bottles, jars, capsules, etc..
Should be stored properly cleaned and dried before packing the products.

3. Finished goods stores: The finished goods transferred from the production area
after proper packing should be stored on proper shelves within an area marked
“quarantine ”. After the quality control laboratory test and experts have checked

the correctness of finished goods then it should be moved to the approves finished
goods stock area.

8.working space

The manufacturing area should provide adequate space for organized placement of
equipment and material 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.
9. Health, clothing, sanitation and hygiene

 Workers should be free from. Contagious disease.

 They should have proper uniform suitable to work.

 Hands should covered with cloths, or synthetic coverings.

 Personal cleanliness, clean towel, soap, separate lavatory for men and women
should be maintained.

 Facility for changing of cloths and cupboards to keep their clothes and belongings
should be provided.

10.Medical services

Annual medical check up of all employees should be done to ensure freedom

from infectious disease. The first aid facility should be available and the health record
of all the employees should be maintained.

11.Machinery and equipment

 Equipment should be according to the size of operation and the nature of product
manufactured

 Semi automatic or automatic machines are available in manufacturing unit such

as crushing, grinding, powdering, boiling, mashing, drying, filling, labelling etc..

 Adequate space should be provided between the equipment.

 Equipment should be. Properly installed and. Maintained with proper cleaning.

 Sops should be followed for Cleaning and maintaining and performance of every
machine should be maintained

12. Distribution records

Records of sale and distribution of each batch of Ayurveda, Siddha and unani
drugs should be maintained to facilitate quick and complete recall of the batch when
needed.
13.Record of market complaints

Manufactures should maintain a register to. Record the complaints as well as

corrective action initiated to prevent repetition regarding the products. Once in a six
months the complaint record have to be sent to the licensing authority. A register
should be available for inspection. Reports of any ADR from the use of drug should.
Be maintained in separate register.

14.Quality control

Every license is required to provide a facility for quality control section in his own
premises or govt approved testing laboratory. The test should be done as per the
Ayurveda, siddha and unani pharmacopoeia standard. There should be 150sq feet
area for quality control section.

15.Requirement of sterile product

Manufacturing area for the production of sterile Ayurveda products the separate
enclosed area should be provided. This area should be aseptic, dust free, moisture less
and should have 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.GLP regulation became a 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 SOPs. 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.

(b) Quality Assurance Program

 Quality assurance personnel should have access to the updated study plans and
SOPs. 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 and reported to the management.

(c)Facilities

 Test system facilities: 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 for the
diagnosis, treatment and control of diseases in order to ensure that there is no
unacceptable degree of deterioration of test systems
 Archive Facilities.: Archive facilities should be provided for the secure storage
recovery of study plans, raw data, final reports, samples of test items and
specimen.Archive design and archive conditions should protect contents from
early deterioration
 Waste disposal: Handing and disposal of wastes should be carried out in such a
way 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 to 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 data 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, handing 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, reference to
test methods, information concerning the sponsor and facility and conduct of the
study.

(h) Reporting of Study Results:

 It includes information on 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 of the study plans, 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 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. 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 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 (HPTLC), gas chromatography (GC), 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 and 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 ingredient. 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 them 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 basically 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 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, 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)Good manufacturing practice for herbal medicines

Good manufacturing practice is 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. GMP are aimed
primarily at diminishing the risks inherent in any pharmaceutical production. Such
risks are essentially of two types: cross contamination (in particular of unexpected
contaminants) and mix-ups (confusion) caused by, for example, false labels being put
on containers. Under GMP:

a)All manufacturing processes are clearly defined, systematically reviewed in the

light of experience, and shown to be capable of consistently manufacturing
pharmaceutical products of the required quality that comply with their specifications

b)Qualification and validation are performed

c)All necessary resources are provided, including:

(1)qualified and trained personnel

(2) Adequate premises and space

(3) Suitable equipment and services

(4) Appropriate materials, containers and labels

(5) Approved procedures and instructions

(6) Suitable storage and transport

(7) Adequate personnel, laboratories and equipment for in-process controls

d) Instructions and procedures are written in clear and unambiguous language,

specifically applicable to the facilities provided

e) Operators are trained to carry out procedures correctly

f) Records are made (manually and/or by recording instruments) during manufacture

to show that all the steps required by the defined procedures and instructions have in
fact been taken and that the quantity and quality of the product are as expected; any
significant deviations are fully recorded and investigated

g)Records covering manufacture and distribution which enable the complete history
of a batch to be traced, are retained in a comprehensible and accessible format

h) The proper storage and distribution of the products minimizes any risk to their
qualify.

i) A system is available to recall any batch of product from sale or supply

j) Complaints about marketed products are examined; the causes of quality defects
investigated, and appropriate measures taken in respect of the defective products to
prevent recurrence.

(i) 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.

(j) 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.

(k)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.

(l) 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,
sensitivity to microbiological contamination, the production, storage of herbal
materials and herbal preparations need special importance.

(m) 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 thestored
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 2°C and 8°C Whereas, frozen materials should be stored below-
18°C.
 Bulk materials are advisable to store them in aerated 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 micro-
organisms brought in with the plant material and to prevent cross- contamination.
 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.
(n) 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 vapours.
 To facilitate cleaning and to avoid cross- contamination, 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.

(o) 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.

(p) 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 regulation.
 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.

(q) 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 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. Myco
toxins, 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 pharmacopoeial
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 choosen 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 need 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.

r) Good practices in production

 Medicinal plants which 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, ie Where the
application of these guidelines starts, should be clearly 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 include 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 un loaded
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 case 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, 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. should be mixed only if it can be guaranteed that the mixture will be
homogeneous. Such processes should be well 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).
 expiry date of the blended batch should be chosen according to the date of
manufacture of the oldest batch in the blend.

s) 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 a 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 of finished
herbal products should be tested.
 Identification test may be based on physical, macroscopic (organoleptic) and
microscopic testes, chromatographic procedures (TLC, HPLC, HPTLC or gas-
liquid chromatography (GLC), spectrometric techniques (ultraviolet to 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 are
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 of markers compouds
is necessary
 The development and execution of quality control methods for herbal materials,
herbal preparations and the 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, the full quantitative composition of the herbal ingredients should be
stated on the product label ,If this is not possible, atleast 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 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.
Objectives :
(a) To contribute to the quality assurance of medicinal plant materials used as the
source.
(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 discussed under section 2.1.2.
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 clearly 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
 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.
 Collectors of plants 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.
 Medicinal plant materials should be collected during the appropriate season or
time period to ensure the best quality
 The best time for collection should be determined according to the quality and
quantity of biologically active constituents .
 When collecting species whose bark is the primary material to be used, the tree
should not be girdled or completely stripped of.
 The collection of medicinal plants in and around active pasture , should be
avoided in order to avoid microbial contamination from animal waste.
 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, other well-
aerated containers that are free from foreign matter.
 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 etc...
 Collecting equipment such as; axes, cutters, saws and mechanical tools, should be
kept clean and maintained in proper condition.

(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.

COMMON TECHNICAL ASPECTS OF GOOD AGRICULTURAL

PRACTICES FOR MEDICINAL PLANTS AND GOOD
COLLECTION PRACTICES FOR MEDICINAL PLANTS

Post-harvest processing

Inspection and sorting

Raw medicinal plant materials should be inspected and sorted prior to primary
processing. The inspection may include:

1. Visual inspection for cross-contamination by untargeted medicinal plants and/or

plant parts;

2. Visual inspection for foreign matter

3. Organoleptic evaluation, such as: appearance, damage, size, colour, odour, and
possibly taste.

Primary processing

Appropriate measures of primary processing are dependent on the individual

materials. These processes should be carried out in conformity with national and/or
regional quality standards, regulations and norms. In some cases, purchasers may
request that specific protocols are followed. These protocols should also comply with
national and/or regional regulatory requirements that apply in the producer and the
purchaser countries. As far as possible, standard operating procedures should be
followed. If modifications are made, they should be justified by adequate test data
demonstrating that the quality of the medicinal plant material is not diminished.

Prior to processing, the medicinal plant materials should be protected from rain,
moisture and any other conditions that might cause deterioration. Medicinal plant
materials should be exposed to direct sunlight only where there is a specific need for
this mode of drying.

Drying

When medicinal plant materials are prepared for use in dry form, the moisture
content of the material should be kept as low as possible in order to reduce damage
from mould and other microbial infestation. Information on the appropriate moisture
content for particular medicinal plant materials may be available from
pharmacopoeias or other authoritative monographs.

Medicinal plants can be dried in a number of ways: in the open air; placed in thin
layers on drying frames, wire-screened rooms or buildings; by direct sunlight, if
appropriate; in drying ovens/rooms and solar dryers; by indirect fire; baking;
lyophilisation; microwave; or infrared devices. When possible, temperature and
humidity should be controlled to avoid damage to the active chemical constituents.
The method and temperature used for drying may have a considerable impact on the
quality of the resulting medicinal plant materials.

Specific processing

Some medicinal plant materials require specific processing to: improve the purity
of the plant part being employed; reduce drying time; prevent damage from mould,
other microorganisms and insects; detoxify indigenous toxic ingredients; and enhance
therapeutic efficacy. Common specific processing practices include pre-selection,
peeling the skins of roots and rhizomes, boiling in water, steaming, soaking, pickling,
distillation, fumigation, roasting, natural fermentation, treatment with lime and
chopping. Processing procedures involving the formation of certain shapes, bundling

and special drying may also have an impact on the quality of the medicinal plant
materials.

Processing facilities

The following elements should be considered when establishing a quality

assurance system and be adapted to the different steps of production and production
sites.

Location

Facilities should preferably be located in areas that are free from objectionable
odours, smoke, dust or other contaminants, and are not subject to flooding.

ROADWAYS AND AREAS USED BY WHEELED VEHICLES

Roadways and areas serving the establishment, within its boundaries or in the
immediate vicinity, should have a hard paved surface suitable for wheeled vehicles.
There should be adequate drainage, and provision should be made for cleaning.

Buildings

Buildings should be of sound construction and maintained in good repair. Dirty

areas, such as those used for drying and milling, must be isolated from clean areas,
preferably in separate buildings. All construction materials should be such that they
do not transmit any undesirable substance to medicinal plant materials. Once
construction is completed, construction materials should not emit toxic vapours. The
use of materials that cannot be adequately cleaned and disinfected, such as wood,
should be avoided unless they would clearly not be a source of contamination.

Buildings should be designed to:

 Provide adequate working space and storage room to allow for satisfactory
performance of all operations;
 Facilitate efficient and hygienic operations by allowing a regulated flow in
processing from the arrival of the raw medicinal plant materials at the premises to the
dispatch of the processed medicinal plant materials;
 Permit appropriate control of temperature and humidity;
 Permit the separation by partition or other means of processes that may cause
cross contamination, especially to isolate dirty areas (drying and milling) from clean
areas;
 Permit control of access to different sections, where appropriate;
 Permit easy and adequate cleaning and facilitate proper supervision of hygiene;
 Prevent the entry of environmental contaminants such as smoke, dust, etc.;
 Prevent the entrance and harboring of pests, livestock and domesticated animals;
 Where appropriate, prevent direct sunlight from entering a particular section.

MEDICINAL PLANT MATERIAL HANDLING AREAS

Floors, where appropriate, should be of waterproof, non-absorbent, washable,

nonslip and non-toxic material, without crevices, and should be easy to clean and
disinfect .

Walls, where appropriate, should be covered with waterproof, non-absorbent and

washable materials, sealed and free from insects, and should be light coloured. Up to
a height appropriate for handling operations, they should be smooth .

Ceilings should be designed, constructed and finished so as to prevent the

accumulation of dirt and minimize condensation, mould development and flaking,
and should be easy to clean.