[PS 147] MODULE 1_WHO GACP (Part 7)

(1) Cultivation and collection of medicinal plants and production of medicinal plant materials (2) Post-harvest processing required for medicinal plant materials (3) Quality control of medicinal plant materials

GACP encompasses (3)

The Japanese Pharmacopoeia and Japanese Standards for Herbal Medicines

Basis for Japanese national quality standards (2)

(1) Be a high quality product (2) Microbiological load is below the minimum contamination level (3) Should be either free from pesticide residues and other foreign matter or below the minimum level of contamination by pesticide residues and other foreign matter

End goals for medicinal plant materials (3)

The Japanese Pharmacopoeia

What is the basis for standard for minimum level of contamination?

"Products produced in compliance with the guideline"

If medicinal plant materials are produced in compliance with this guideline, they should be described as _____ for the information of the general public.

TRUE

T/F: In the production process of raw materials for use in the production of Kampo medicines and crude drug products, the raw materials should be kept as free as possible from microbial and other contaminants and residues such as pesticides.

TRUE

T/F: Materials should be well washed

False; the skin of the material should be peeled and the materials should be dried at low temperature in order to avoid any change in the color and odor of the materials

T/F: The skin of the material should not be peeled and the materials should be dried at high temperature in order to avoid any change in the color and odor of materials

False; medicinal plants should not be cultivated in areas where the land and/or the soil is in a hazardous condition

T/F: Medicinal plants should be cultivated in areas where the land and/or the soil is in a hazardous condition

TRUE

T/F: Hazardous conditions include high risk of contamination by hazardous substances such as heavy metals, agricultural chemical agents, and other industrial waste.

Well-drained and well-irrigated soils

The preferred soil conditions for the cultivation of medicinal plants

False; should not be contaminated

T/F: Water for irrigation can be contaminated by domestic animals and human materials

False; cows are prohibited from entering cultivation sites

T/F: Cows may enter cultivation sites

False; fertilization can also be done immediately after the first harvest

T/F: Land should be manured/fertilized with organic compost only before planting

False; contaminated water should not be used

T/F: Contaminated water can be used at the time of harvest

TRUE; weeds could be an indicator of good cultivation conditions

T/F: Medicinal plants should be planted in an area of land where weeds can grow

False; should only be handled by experienced personnel

T/F: Pesticides and herbicides can be handled by anyone

Should be done prior to harvest at an appropriate interval and with consideration of effective duration of agent used

Application of pesticides and herbicides should be done in what conditions?

False; it is preferred to harvest during dry, low humidity conditions

T/F: Harvesting is ideal to be carried out in wet conditions

TRUE

T/F: Harvesting equipment should be clean and well maintained; they should also be kept free from accumulated plant material and other debris

TRUE

T/F: Cutter blades should be adjusted to avoid soil pick-up

TRUE

T/F: All containers used for primary collection of the crop must be kept free from previously accumulated plant material

Vermin

Containers for primary collection, when not in use, must be kept in a dry place free from ___ and inaccessible to farm and domestic animals.

TRUE

T/F: Damaged and spoiled crop material should be sorted and discarded

Dry sacks, baskets, trailers or hoppers

Harvested material should be collected in (3)

False; must not be collected on the ground

T/F: Harvested material can be collected on the ground

False; plastic should not be used for harvest

T/F: Plastic sacks can be used for harvesting

False; should not be overfilled

T/F: Sacks can be overfilled

False; stacking may lead to compaction of harvested material

T/F: Stacking of sacks with harvested material can be done

Short

The time between harvest and transport of crop to the drying site should be kept as ____ as reasonably practicable

(1) Pests (2) Farm and domestic animals

The harvested crop should be protected from (2)

TRUE

T/F: The crop should be unpacked as soon as possible on arrival at the drying facilities

False; should not be exposed to direct sunlight and rain for prolonged period

T/F: Harvested plants can be exposed to direct sunlight and to rain for prolonged periods

TRUE

T/F: Drying facility should be constructed so as to protect the crop from birds, insects, farm and domestic animals

TRUE

T/F: Drying racks should be kept clean and regularly maintained

Thin layers; wire mesh racks; intermittently

Crops should be placed in ___ layers, on ____ standing off the floor to allow free air circulation, and stirred ___ to ensure uniform drying and prevent composting.

False; this is not recommended

T/F: It is recommended to dry off the floor and in direct sunlight

Discolored, moldy, and damaged material

Dried crops should be inspected and sieved or winnowed to remove ___, ___ and ___ material and soil, stones and other foreign matter. Sieves should be kept clean and maintained regularly.

TRUE

T/F: Clearly marked waste bins should be provided, emptied daily and cleaned.

False; dried and drying crops should be protected from pests and farm and domestic animals

T/F: Dried and drying crops can be exposed to pests and farm and domestic animals

False; dried crops should be packed as soon as possible for protection and to lessen the opportunity of pest infestation

T/F: Dried and drying crops can be packed at a later time

Clean, dry; new

T/F: After removal of damaged material and foreign matter, the sound dried crop should be packed in __, ___ sacks, bags or boxes, preferably __.

False; should be dry, not humid

T/F: Storage conditions of packed materials should be clean and humid, free from pests and inaccessible to animals

True; provided that they are well cleaned and dried before use

T/F: Reusable packaging materials can be reused in packaging

Away; off

The packed crop should be stored in a dry place ____ from the wall and ___ the ground and be protected from pests and farm and domestic animals

Dry; well; diurnal

Packed dried crop should be stored in a __, __ ventilated building, with minimal variation in __ temperature and with good air ventilation.

Wire screens

Shutter and door openings should be protected by __ to keep out pests and farm and domestic animals

(1) In a building with concrete floors (2) On pallets (3) Away from the wall (4) Well separated from all other crops

It is recommended that packed dried crops should be stored ___ (4)

Vented; temporary

For bulk deliveries, the use of __ containers for transport and storage in __ warehousing is highly recommended to minimize contamination risks

False; fumigation shall only be done when necessary by trained personnel

T/F: It is essential to fumigate storage and transport facilities to control pests

TRUE

T/F: Chemicals used as pesticides, fumigants, etc., should be kept in a separate area

False; dry cleaning

T/F: Wet cleaning is recommended for cleaning of equipment

TRUE

T/F: If water is used in cleaning, equipment should be dried as quickly as possible.

TRUE

T/F: All equipment should be installed to allow easy access and should be well maintained and cleaned regularly.

False; wooden equipment should be avoided

T/F: Use of wood for any part of equipment used is recommended

False; wood should not be treated with chemicals as it could be a source of taint (e.g. chlorophenols)

T/F: When using equipment with wooden parts, it is recommended to subject it first to chemical treatment

(1) Maintain a high degree of personal hygiene (2) Be provided with suitable changing facilities and toilets with hand washing facilities

Personnel handling medicinal plant material should (2)

False; personnel with disease should not work with herbal materials since the disease can be transmitted through medicinal plant materials

T/F: Personnel with disease can work in the herbal material handling area provided that they are wearing protective equipment such as masks

False; Personnel with open wounds, sores, and skin infections should be transferred away from herbal materials handling areas until completely recovered

T/F: Personnel with open wounds, sores, and skin infections can work in herbal materials handling areas provided that they their areas of infection are completely covered

Fertilizer, pesticide, and herbicide

Keeping records of __, __ and __ used on each batch of harvested material is highly desirable.

Methyl bromide or phosphine

The use of __ or __ for fumigation of herbal materials should be: notified to the buyer, recorded in shipment papers.

TRUE

T/F: Training and education of personnel, whether handling crops or managing crop production, in appropriate production techniques is highly recommended

Producer's and the buyer's

Compliance with the recommendations of the GACP should be checked through regular inspection visits by the __ and the __ representatives with expertise in good agricultural and hygiene practice

TRUE

T/F: Specifications for herbal materials can be agreed between the producer and the buyer

(1) Active principles and characteristic constituents (2) Microbial load (3) Visual and sensory properties (4) Pesticide residues and heavy metals

Enumerate the specification that can be communicated between producer and buyer (4)