Part 2 Good Manufacturing Practices for Pharmaceuticals
Chapter 2 Good Manufacturing Practices for Chinese Herbal Medicines
Section 3 FactoryBuildings and Facilities
Chinese herbal medicine factory buildings shall be well constructed and safe; manufacturing, processing and packaging areas shall be completely separated from offices, reception rooms, laboratories, restaurants and their associated lavatories; the use of asbestos shall be avoided.
The buildings described in the preceding Paragraph shall be designed to prevent the entry of rodents, insects and dust; interior ceilings, walls and floors shall be smooth and free of cracks and crevices, easy to clean, and non-conducive to the collection of dust; where necessary, materials that are easily cleaned and disinfected, such as epoxy resins shall be used. Interior ducts shall be constructed of materials that do not easily collect dust, and shall be hidden where possible; drainage facilities and drainage exits shall be equipped to prevent wastewater backflow.
Areas at Chinese herbal medicine factories used for the storage of raw materials, product containers, caps, and labeling and packaging materials, and for the manufacture, processing, re-packaging, packaging and storage of products, shall be appropriately sized and located. These areas shall be suitably arranged, with operation areas clearly delineated by production type. Moreover, appropriate work space and levels of insulation and cleanliness shall be established as needed.
Levels of cleanliness, as mentioned in the preceding Paragraph, shall be established in accordance with the type of product being manufactured. Operation areas requiring the same level of cleanliness shall be grouped together; buffer zones or entry rooms shall be established between areas with different levels of cleanliness, and different colors or types of work clothes may be used to indicate the cleanliness levels of the various operation areas.
No operation area may be used as a passageway by personnel from other operation areas; passageways for people and for the transport of goods shall be separate, and shall not cross.
Facilities for the storage of raw materials, product containers, caps, labeling and packaging materials, semi-finished or intermediate products, and products shall be given “pre-inspection,” “approved for use” and “not approved for use” designations; if items are present that need to be kept frozen or toxic, appropriate storage facilities shall be established.
Semi-finished or intermediate products shall be stored separately; if they are not stored separately, special care shall be taken to prevent contamination and degradation of quality.
Where Chinese herbal medicine factories manufacture environmental sanitation agents, environmental sanitation agent manufacturing, processing and re-packaging areas, as well as raw material storage facilities, shall be separated from pharmaceutical manufacturing, processing and re-packaging areas by a distance of no less than eight meters.
Where Chinese herbal medicine factories manufacture pharmaceutical feed additives, the pharmaceutical feed additive operation area shall be independent from other operation areas.
Where Chinese herbal medicine factories use their pharmaceutical production facilities to manufacture food products, cosmetics or general goods, care shall be taken to prevent cross-contamination, and validation procedures shall be carried out.
All operation areas in Chinese herbal medicine factories shall be equipped with appropriate illumination and ventilation facilities; where necessary, aforesaid areas shall also be equipped with appropriate facilities for the regulation of temperature and humidity.
Each production and processing area shall, in accordance with its air purity requirements, be equipped with appropriate air filtration systems, including pre-filters and particulate filters.
In areas for the storage of raw materials, products, semi-finished or intermediate products, and areas where products are manufactured, processed, re-packaged or packaged, conditions conducive to the prevention of quality degradation shall be maintained.
For Chinese herbal medicine factory production areas involving hazardous or flammable raw materials, solvents, semi-finished or intermediate products, or products, appropriate protective, first-aid and segregation facilities shall be established.
Facilities used in the manufacturing, processing and re-packaging process shall be airtight from start to finish; where facilities are not airtight and dust or hazardous gases are produced, local exhaust ventilation systems and negative pressure procedures shall be established.
Lighting, switches, sockets, motors and other electric devices for operation areas that produce dust, where organic solvents are used, or where hazardous substances are present, shall, as needed, be explosion-proof, airtight, or isolated from operation area.
Boilers, pressure vessels, cranes and other types of dangerous equipments and facilities shall be inspected and approved in accordance with relevant regulations before use.
Chinese herbal medicine factories shall, as needed, establish employee lounges and shower rooms outside of work areas.
Manufacturing and processing areas shall be installed with appropriate lavatory facilities, and wastewater, garbage and other waste materials produced in aforesaid areas shall be treated in a safe and sanitary manner. Lavatory facilities shall be separated from work areas.
Chinese herbal medicine factories shall, as needed, install facilities for the processing of general use and wastewater, and facilities for the production of boiler water or distilled water. Water supply facilities shall be kept from contaminating products.
Container washing facilities shall be installed in Chinese herbal medicine factories.