In the plane of the pharmaceutical plant, not all are production plants, and not all are clean areas.
According to WHO's GMP, the following zones can be divided within the plane of a pharmaceutical plant:
Production zone - the area directly engaged in the production of pharmaceutical products, with cleanliness requirements.
Quality control area - with quality control laboratories, calibration rooms, instrumentation rooms, etc., with cleanliness requirements.
Storage area--store all kinds of materials and products,
Materials: such as starting raw materials, packaging materials}
Products; such as intermediate products, to be packaging materials and finished products, to be inspected products, qualified products, unqualified products, reprocessed products, recycled products.
There are certain requirements for temperature and humidity and cleanliness, and special attention should be paid to the special storage requirements for highly active materials, narcotics, drugs with the danger of misuse, and items requiring fire and explosion protection.
Weighing area - the weighing of starting materials, there are certain cleanliness requirements or dust control requirements. Can be placed in the storage area.
Ancillary areas - including changing, storage, laundry, lavatory, rest, maintenance and animal rooms. Except for the animal room and second shift and laundry,
Generally no cleanliness requirements.
GMP (2010) for the pharmaceutical plant plane is clearly divided into production areas, storage areas, quality control areas and auxiliary areas. Its specific content and the WHO GMP provisions are slightly different:
The production area contains storage area (different from the storage area), weighing room, packaging area, intermediate control area. Storage area contains material sampling area. Quality control area contains a variety of laboratories, in addition to the instrument room, but also includes a laboratory animal room. Auxiliary area in addition to the animal room, and WHO's GMP similar. Or, pick up the degree of air cleanliness requirements, the plane is divided into three areas:
In the first two areas, only the necessary process equipment should be set up to minimize the clean area, control layer business, in order to reduce investment and energy consumption.