Pharmaceutical 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 said areas shall be treated in a safe and sanitary manner. Lavatory
facilities shall be separated from work areas.
Article
45. Pharmaceutical 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.
Article
46. Container washing facilities shall be installed; where container
washing facilities are used to wash containers for eye drops,
injectables, or biopharmaceutical or biotechnology products, special
care shall be taken to prevent contamination, and said facilities shall
be installed away from other container washing facilities.
Article
47. Pharmaceutical factories shall carry out the manufacturing,
processing and re-packaging of sterile products in aseptic room areas.
The aseptic room areas mentioned in the preceding Paragraph shall, as needed, be installed with the following facilities:
(1) Floors, walls and ceilings that are easily cleaned and disinfected;
(2) Temperature and humidity control systems;
(3) High performance air filtration systems capable of maintaining positive pressure;
(4) Work area surveillance systems;
(5) Cleaning, disinfection, and other systems for maintaining sterile conditions.
Operation
areas for sterile products that cannot be sterilized during the final
stage of production must not only comply with the preceding Paragraph,
but must also be installed with high performance air filters and laminar
flow facilities for the circulation of sterile air. Furthermore,
excessive traffic (personnel and objects) into and out of said areas
shall be avoided.
Chapter 4 Facilities
Article
48. Facilities at pharmaceutical factories used for the manufacture,
processing, re-packaging, packaging and storage of products shall be
appropriately designed, sized and located for ease of use, cleaning and
maintenance.
Facilities needed for the production of different dosage forms shall be positioned according to manufacturing process sequence.
Article
49. The surfaces of facilities at pharmaceutical factories that come
into direct contact with raw materials, semi-finished products,
intermediate products or products shall be made of non-reactive,
non-releasing and non-adsorptive materials; where any process requires
the use of lubricants, coolants or other similar substance, said
substances may not come into contact with raw materials, product
containers, caps, semi-finished products, intermediate products or
products.
Article
50. Facilities and appliances at pharmaceutical factories used for the
manufacture, processing, re-packaging, packaging and storage of
products shall be regularly cleaned and maintained, and operational
procedures shall be established in writing.
Facilities
and appliances in aseptic room areas shall be made of materials that
are easily cleaned, dried and disinfected, and shall be regularly
cleaned, disinfected and maintained.
Article
51. The production capacities of mechanical facilities used at
pharmaceutical factories to produce a single product shall be carefully
coordinated to ensure consistency of product quality.
Automated
machinery and electronic facilities used in the manufacturing process,
as well as software and equipment related to computers or to the
manufacture, processing, re-packaging, packaging or storage of
pharmaceuticals, shall be regularly recalibrated, inspected, examined
and maintained.
Computer
systems used to control production and production management records
shall be properly maintained, and alterations may not be made to said
systems without permission from the personnel in charge; all data that
is input or printed shall be checked for accuracy, and its period of
validity shall be determined based on the complexity and reliability of
the computer system.
Air used by drying facilities during the manufacturing process shall first be treated with a purification filter.
Facilities
used to manufacture pharmaceuticals for internal and external use shall
be kept strictly separate, and may not be used interchangeably.
Pharmaceutical
factories shall install weighing facilities that comply with
regulations, and shall recalibrate said facilities regularly.
Article
52. Where a pharmaceutical factory manufactures, processes or packs
injectables, and has not installed filtration facilities capable of
filtering out fibers, said factory may not use liquid filtration
facilities that can possibly release fibers.
Article
53. Pharmaceutical factories shall keep facilities and equipment for
the production of pharmaceuticals for human and animal use separate, and
these two types of production may not be carried out in the same
structure unless the two areas are completely separated. However,
pharmaceuticals for animal use that comply with the standards governing
drugs for human use are not subject to this restriction.
Article
54. Pharmaceutical factories shall, in accordance with the
requirements of the products being manufactured, install necessary
manufacturing, processing, re-packaging and packaging facilities.
Article
55. Pharmaceutical factories shall, in accordance with their
specification testing requirements for raw materials, semi-finished
products, intermediate products and products, establish testing
departments and appropriate testing facilities. However, if tests are
conducted on a contract basis by an organization approved by the
competent authority, in accordance with the Contract Drug Manufacturing
and Testing Operating Principles, and clear documentation is provided,
establishment of said facilities may be waived.
Testing
departments shall include testing and instrument laboratories.
Instrument laboratories shall be separate from testing laboratories, and
shall be kept at an appropriate temperature and level of humidity and
air purity; testing laboratories shall be installed with sufficient and
easy to use test benches, test stands, drug cabinets, fume hoods, water
supply and washing facilities, as well as electric heating, thermostatic
and drying facilities, and shall also be stocked with utensils and
containers, chemical reagents and solutions, standard solutions and
other necessary items.
Where
eye preparations, injectable drugs, biopharmaceutical or biotechnology
products are produced, areas, facilities and equipment necessary for
conducting plate count, sterility tests and other tests shall be
installed as needed; said areas and facilities shall be equipped with
necessary culture mediums and control strains.
Where
injectable drugs and biopharmaceutical or biotechnology products are
produced, areas, facilities and equipment necessary for conducting
pyrogen tests shall be installed as needed; said areas and facilities
shall be equipped with necessary rabbits and breeding areas.
Where
antibiotics and biopharmaceutical or biotechnology products are
produced, areas, facilities and equipment necessary for conducting
safety tests shall be installed as needed; said areas and facilities
shall be equipped with necessary animals and breeding and observation
areas.
Where
antibiotics, hormones and biopharmaceutical or biotechnology products
are produced, areas, facilities and equipment necessary for conducting
bioassays shall be installed as needed.
The
specifications of aseptic rooms and dissection laboratories shall be
determined in accordance with the requirements of the tasks to be
performed; microorganism strains, culture mediums and animals necessary
for conducting bioassays shall be adequately stocked and maintained.
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