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 harbouring 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. Where appropriate, floors should slope sufficiently for liquids to drain into trapped outlets.

♦ 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 and without crevices, and should be easy to clean and disinfect. Where appropriate, angles between walls, between walls and floors, and between walls and ceilings should also be sealed and covered to facilitate cleaning.

♦ 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.

♦ Windows and other openings should be constructed so as to avoid accumulation of dirt, and those that open should be fitted with insect-proof screens. Screens should be easily removable for cleaning and kept in good repair. Internal window sills, if present, should be sloped to prevent use as shelves.

♦ Doors should have smooth, non-absorbent surfaces and, where appropriate, be self-closing and close-fitting.

♦ Stairs, lift cages and auxiliary structures such as platforms, ladders and chutes should be situated and constructed so as not to cause contamination to medicinal plant materials. Chutes should be constructed with inspection and cleaning hatches.

♦ Overhead structures and fittings should be installed in such a manner as to avoid contamination of medicinal plant materials (both raw and processed) by condensation and drip, and should be protected to prevent contamination in case of breakage. They should not hamper cleaning operations. They should be insulated, where appropriate, and be designed and finished so as to prevent the accumulation of dirt and to minimize condensation, mould development and flaking. They should be easy to clean.

♦ Living quarters, food preparation and eating areas, changing facilities, toilets and areas where animals are kept should be completely separated from and should not open directly on to medicinal plant material handling areas.

Water supply

An ample supply of water, under adequate pressure and at suitable temperature, should be available with appropriate facilities for its storage, where necessary, and distribution, and with proper protection against contamination.

♦ Ice should be made from potable water; it should be manufactured, handled and stored so as to protect it against contamination.

♦ Steam used in direct contact with medicinal plant materials or surfaces in contact with medicinal plant materials should contain no substances that may be hazardous to health or may contaminate the medicinal plant materials.

♦ Non-potable water used for steam production, refrigeration, fire control and other similar purposes not connected with processing should be carried in completely separate pipes, identifiable preferably by colour, and with no cross-connection with or back siphonage into the system carrying potable water.

♦ Potable water should be used for washing and wet sterilization procedures.

Effluent and waste disposal

Facilities should have an effective effluent and waste disposal system, which should at all times be maintained in good order and repair. All effluent pipes (including sewerage systems) should be large enough to carry peak loads and should be constructed so as to avoid contamination of potable water supplies.

Changing facilities and toilets

Adequate, suitable and conveniently located changing facilities and toilets should be provided. Toilets should be designed so as to ensure hygienic removal of waste matter. These areas should be well lit, ventilated and, where appropriate, heated. Hand-washing facilities with warm or hot and cold water, a suitable hand-cleaning preparation and hygienic means of drying should be provided adjacent to toilets and located so that employees have to pass them when returning to the processing area. Elbow-operated taps are desirable and, where hot and cold water is available, mixer taps should be fitted. If paper towels are supplied, a sufficient number of towel dispensers and waste receptacles should be provided near to each washing facility. Notices should be posted directing personnel to wash their hands after using the toilet.

Hand-washing facilities in processing areas

Adequate and conveniently located facilities for hand-washing and a hygienic means of drying should be provided whenever the process demands. Where appropriate, facilities for hand disinfection should also be provided. Warm or hot and cold water and a suitable hand-cleaning preparation should be provided. Elbow-operated taps are desirable and, where hot and cold water is available, mixer taps should be fitted. If paper towels are supplied, a sufficient number of towel dispensers and waste receptacles should be provided adjacent to each washing facility. The facilities should be furnished with properly trapped waste pipes leading to drains.

Disinfection facilities

Where appropriate, adequate facilities for cleaning and disinfection of working implements and equipment should be provided. These facilities should be constructed of corrosion-resistant materials, should be easy to clean, and should be fitted with hot and cold water supplies.

Lighting ⁷

⁷ These values have been adapted from Codex Alimentarius Code of Practice - General Principles of Food Hygiene (13).

Adequate natural or artificial lighting should be fitted throughout the facility. Where appropriate, the lighting should not alter colours and the intensity should be not less than:

♦ 540 lux at all inspection points
♦ 220 lux in work rooms
♦ 110 lux in other areas.

Lighting fixtures and light bulbs suspended over medicinal plant materials at any stage of processing should be of a safety type and protected to prevent contamination of the medicinal plant materials in case of breakage.

Ventilation

Adequate ventilation should be provided to prevent excessive heat, steam condensation and dust and to remove contaminated air. Air should never flow from a dirty area to a clean area. Ventilator openings should be provided with a screen or other protective enclosure of non-corrosive material. Screens should be easily removable for cleaning.

Storage of waste and unusable materials

Facilities should be provided for the storage of waste and unusable materials prior to removal from the premises. These facilities should be designed so as to prevent access to the waste or unusable materials by pests and to avoid contamination of medicinal plant materials, potable water, equipment and buildings of the premises. Clearly marked waste bins should be provided and emptied daily.