[PS 147] MODULE 1_WHO GACP (Part 5)

Good Agricultural Practice for Traditional Chinese Medicinal Materials

Title of Annex 1

Traditional Chinese medicinal material

Refers to raw medicinal material produced by primary processing at the place of origin after collecting the medicinal parts of plants and animals intended for medicinal purposes.

Manufacturers of traditional Chinese medicinal

Refer to enterprises of a certain scale which follow certain procedures in the production process, such as the cultivation of medicinal herbs or animal husbandry, primary processing, packaging and storage of medicinal material.

Maximizing sustainable output

Refers to the maximum output of sustainable production (collection) with no harm caused to the ecological environment.

Genuine medicinal material

Refers to traditional Chinese medicinal material with specific properties, originating from specific locations or produced through specific production techniques and processing methods

Seeds, fungal spores and propagation material

Refer to parts, tissues and cells of plants as well as hyphae and fungal seeds which can be used for propagation; and breeding stock, young animals and eggs.

Comprehensive prevention and control of diseases and insect pests

Refers to keeping the harm caused by diseases and insect pests below the economic threshold by appropriately implementing biological, agricultural and chemical methods as well as other effective ecological measures that are safe, efficient, affordable, easy to use, and suitable for local conditions with an overall view of biological and environmental circumstances and based on the principle of giving priority to prevention, so as to achieve the aim of improving economic efficiency and increasing ecological benefits.

Semi-wild animals and plants intended for medicinal purposes

Refer to wild animals and plants intended for medicinal purposes or those which have reverted to wild life, but which have been subject to appropriate human care and management, such as intertilling, weeding, fertilization or feeding.

To standardize the production of traditional Chinese medicinal material

Purpose of Annex 1

B level standard for atmospheric environment quality

Relevant national standards for the atmospheric conditions of production sites

B level standard for soil quality

Relevant national standards for the soil conditions of production sites

Quality standard for agricultural irrigation water

Relevant national standards for the drinking water for irrigation of production sites

Quality standard of drinking water for human consumption

Relevant national standards for the drinking water for animals intended for medicinal use of production sites

False. Both their Chinese name and the scientific name should be recorded.

T/F: For TCM, it is required for animals, cultivated herbs or those collected from wild life that are intended for medicinal use to be accurately identified by the Chinese name only.

(1) The nutritional requirements of medicinal herbs (2) The supporting capacity of the soil

Type, timing and quantity of fertilization for TCM should be determined by __ (2)

False. Largely organic.

T/F: Fertilizer should be largerly inorganic in nature.

False. Limited use may be made of chemical fertilizer according to the needs of various species of medicinal herbs for their growth and development.

T/F: It is never allowed to use chemical fertilizer for cultivation of TCM.

False. It is permissible to use farm manure which has been thoroughly composted to meet harm-free sanitary standards.

T/F: Farm manure is not allowed in the fertilizers used in TCM cultivation.

False. It is prohibited to use these.

T/F: It is permissible to use household garbage, industrial and hospital wastes or human feces as fertilizer in TCM cultivation.

Timely and proper irrigation and drainage

To maintain good soil ventilation, this should be carried out.

(1) The pattern of water requirements for medicinal herbs during different periods of growth and development (2) Climatic conditions

Timely and proper irrigation and drainage should be carried out in accordance with the following (2)

False. In fact, only the smallest effective dosage of pesticide should be used.

T/F: It is recommended that the use of pesticides be done for the cultivation of TCM.

False. Highly effective, low-toxicity, and low-residue

T/F: Highly effective, low-toxicity, and high-residue pesticides should be selected in accordance with the provisions of the Regulations for Pesticide Management in the People's Republic of China.

(1) Living environment of animals (2) Food habits and behavior of animals (3) Ability of animals to adapt to the environment (4) Corresponding animal husbandry regulations and management system

Basis of methods and practices of animal husbandry (4)

(1) Patterns of seasonal and daily activity (2) Different life cycles (3) Physiological characteristics

Basis of animal feed preparation and administration (3)

(1) Season (2) Air temperature (3) Ventilation

Basis of timing and frequency of water supply (3)

TRUE

T/F: Herbivores should, as far as possible, meet their needs for water through eating large quantities of green and juicy fodder.

Resting habits and behavior

Fixed structures with adequate space and necessary safety facilities should be set up in accordance with __ (2)

TRUE

T/F: Animal husbandry quarters should be rationally designed with consideration given to appropriate population density in the case of gregarious (i.e. living in flocks or loosely organized communities) animals.

Quarantine

Where sick animals should be put into if they are found.

Prevention

Disease control of animals mainly rely on this principle.

TRUE

T/F: Animals suffering from infectious diseases should be immediately put to death and incinerated or deeply buried.

(1) Quality of the product (2) Yield of the plants per unit area or number of animals raised (3) Conventional harvesting practices

Basis of appropriate harvesting time (including harvesting seasons and years) and methods (3)

(1) By refrigeration (2) In sand (3) In jars (4) By biological conservation

Fresh products could be stored __ (4)

FALSE. It should be avoided to the extent possible, but if their use is required, it should conform to relevant national regulations on food additives.

T/F: It is not permitted to use conservatives and preservatives.

Conventional

__ methods should be used for processing genuine medicinal material.

To eliminate substandard products and foreign objects.

Why is it necessary to inspect TCM prior to packaging?

(1) Product name (2) Specifications (3) Origin (4) Batch number (5) Packaging date (6) Manufacturer

Necessary information found on each package of medicinal material (6)

(1) Product name (2) Specifications (3) Origin (4) Batch number (5) Weight (6) Packaging assignment number (7) Packaging date

Records of batch packaging should be kept. It includes __ (7)

TRUE

T/F: Fragile medicinal material should be packaged in strong boxes.

Toxic, narcotic and valuable medicinal materials

These medicinal materials should be specifically packaged with corresponding labels.

Bulk transport

In case of __ transport, medicinal material should not be placed in the vicinity of toxic or noxious substances or those which may affect the taste or smell of the material.

To maintain dryness

Why should transport containers be relatively well aerated?

TRUE

T/F: The floor of the storage should be tidy, without cracks and easy to clean.

FALSE. Medicinal material should be stored on shelves which keep the material a sufficient distance from the walls.

T/F: Medicinal material should not be stored on shelves.

(1) Environmental surveillance and hygiene control (2) Inspecting production resources, packaging material and medicinal material, and issuing inspection reports (3) Developing training programmes and supervising their implementation (4) Preparing and managing quality control documentation, and managing all kinds of original records concerning production, packaging and inspection, etc.

Principal functions of the quality control department (4)

FALSE. An inspection should be made of each batch of medicinal material by the quality control department before packaging.

T/F: Inspection is done every other batch of medicinal material by the quality control department before packaging.

(1) The properties and identification of the medicinal material (2) Foreign matter (3) Moisture content (4) Ash content and content of ash insoluble in acids (5) Seepage (6) Marker substances or content of active ingredients

The extent of the inspection of medicinal material before packaging should at least include __. (6)

Personnel who carried out the inspection; and Persons in charge of the quality control department

Inspection reports should be signed by __.

(1) Should have basic understanding of Chinese pharmacy, agronomy or animal husbandry (2) Should have received training in production techniques, safety and hygiene

Requirements for all personnel involved in the production of traditional Chinese medicinal material (2)

Should receive training and be examined at regular intervals.

Requirement for personnel involved in the production of traditional Chinese medicinal material

(1) Should have received at least two years of higher education in pharmacy or agronomy or other relevant fields (2) Should have practical experience in the production of medicinal material

Requirements for persons-in-charge of technological matters at production sites for medicinal material (2)

(1) Should have completed at least two years of higher education (2) Should have experience in the quality control of medicinal material

Requirements for persons-in-charge of quality control departments (2)

Should have good knowledge of cultivation techniques, particularly the use of pesticides and protection techniques.

Requirement for personnel working in the fields

Should have good understanding of animal husbandry technique.

Requirement for personnel involved in the animal husbandry

Should receive medical check-ups at regular intervals.

Requirements for personnel involved in processing, packaging and inspection

FALSE. Persons suffering from infectious diseases, skin disease or open wounds [should not] be allowed to perform functions which involve direct contact with medicinal material.

T/F: Persons suffering from infectious diseases, skin disease or open wounds should may be allowed to perform functions which involve direct contact with medicinal material.

TRUE

T/F: Specific persons should be designated by the manufacturer to be responsible for inspecting environmental sanitation and personal hygiene.

(1) Origin of seeds, fungal spores and propagation material (2) Production techniques and processes

Records of the entire production process for TCM should include __. (2)

(1) Planting time (2) Quantity and area of medicinal herbs (3) Growth of seedlings (4) Transplantation (5) Kind of fertilizer used (6) Time, amount and method of its use (7) Type of pesticide used (e.g. insecticides, fungicides and herbicides (8) Amount, time, and method of its use

Information needed in Production techniques and processes IN PLANTS for recordkeeping of the entire production process for TCM (8)

(1) Daily records of animal husbandry (2) Turnover plans, records of selection and breeding (3) Records of births and the production of eggs, records of diseased cases (4) Death reports (5) Death registration forms (6) Statistical forms for disease control and vaccination (7) Feed preparation forms (8) Feed consumption records (9) Pedigree registration forms, offspring identification forms

Information needed in Production techniques and processes IN ANIMALS INTENDED FOR MEDICINAL PURPOSES for recordkeeping of the entire production process for TCM (8)

(1) Time of collection (2) Collected amount(3) Fresh weight (4) Processing (5) Drying (6) Reduced weight after drying (7) Transportation (8) Storage of medicinal parts (9) Meteorological data and micro-climatic records (10) Evaluation of the quality of the medicinal material (e.g. records of the properties and inspection results of the medicinal material)

Information needed in Production techniques and processes FOR GENERAL MEDICINE MATERIAL for recordkeeping of the entire production process for TCM (8)

At least 5 years

All original records, production plans and records of their implementation, contracts and written agreements should be put on file and kept for __.