藥物製造工廠設廠標準

This set of standards is formulated in accordance with regulations of Paragraph 5, Article 57 of the Pharmaceutical Affairs Act (hereafter referred as the Act).

The facility/premises/equipments and sanitary conditions of a medicament factory shall comply with this set of standards; matters not provided for herein shall be governed by other relevant laws and regulations.

1When domestic medicament manufacturers of the new establishment, relocation, expansion, resumption of operations, or addition of new active pharmaceutical ingredients, dosage forms, processes (packaging and labeling), products, are in compliance with Part 2 of this set of standards and the Factory Management Guidance Act, the competent industry authorities of municipalities or counties (cities) shall issue them the factory registration documents, or approve their alterations of registration; the competent health authorities of municipalities or counties (cities) shall issue them the Pharmaceutical Business License, or approve their alterations of registration.

2When domestic medicament manufacturers with the factory registration documents and Pharmaceutical Business License in accordance with the preceding Paragraph are found through inspection to be in compliance with Pharmaceutical Good Manufacturing Practice Regulations, regulated that manufacturers shall be issued the medicament manufacturing license for those items under good manufacturing practices for drug (medicinal products) or good manufacturing practices for medical devices by inspections by the central competent health authority.

3When foreign medicament manufacturers are found through inspection to be in compliance with the Pharmaceutical Good Manufacturing Practice Regulations, said manufacturers shall be issued pharmaceutical GMP certificates or medical device GMP certificates of qualified items by inspections by the central competent health authority.

1Medicament factories shall possess the following basic requirements and common facilities:

2(1) Factory sites shall be situated in sanitary locations with fresh air; factory production, processing and packaging areas shall be constructed in accordance with relevant building codes, and located at a sufficient distance from factory boundaries to prevent pollution and fires; safety measures against pathogens implemented at factories and facilities that manufacture biopharmaceuticals or biotechnology products may not interfere with public health or safety; factory sewers shall be covered to prevent the entry and exit of animals to spread pathogens.

3(2) Factory buildings shall be solid and safe, and designed to prevent 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 may be used; all operation areas shall be well illuminated and ventilated; where necessary, equipment for the regulation of temperature, humidity and air clean may be installed.

4(3) Operation areas shall be clearly delineated (e.g. powder manufacturing room, liquid manufacturing room); in factories that environmental sanitation medicines are also manufactured, the operation areas shall be separated by an appropriate distance from manufacturing factories of other medicines; when necessary, separation walls may be installed.

5(4) Warehouses for the storage of raw materials, supplies, semi-finished products and end products shall be established.

1Facilities used to manufacture pharmaceuticals for internal use and intense toxic drugs for external use shall be kept strictly separate, and may not be used interchangeably.

2Facilities and equipment used to manufacture pharmaceuticals for humans and animals should be kept separately. Separate areas should be designated for manufacturing pharmaceuticals for humans and animals, unless those for animals meet the standard for humans.

1Factories that manufacture pharmaceutical powders shall, as needed, install the following facilities:

2(1) Pulverizing facilities;

3(2) Screening facilities;

4(3) Mixing facilities;

5(4) Drying facilities;

6(5) Dust collection facilities;

7(6) Other relevant facilities.

1Factories that manufacture hard/soft capsule pharmaceuticals shall, as needed, install the following facilities:

2(1) Pulverizing facilities;

3(2) Screening facilities;

4(3) Mixing facilities;

5(4) Drying facilities;

6(5) Gelatin blending facilities;

7(6) Soft gelatin processing facilities;

8(7) Soft capsule filling and pressing facilities;

9(8) Automatic or semi-automatic capsule filling facilities;

10(9) Dust collection facilities.

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1Factories that manufacture pharmaceutical granules, tablets (including tablets for eye use), coated tablets, or pills shall, as needed, install the following facilities:

2(1) Pulverizing facilities;

3(2) Screening facilities;

4(3) Mixing or annealing facilities;

5(4) Drying facilities;

6(5) Granulating facilities;

7(6) Milling facilities;

8(7) Tablet pressing or pill making facilities;

9(8) Gelatin or coating syrup blending, atomizing, coating, ventilation, drying, polishing facilities;

10(9) Molding machines, buffing machines,

1Factories that manufacture pharmaceutical emulsions shall, as needed, install the following facilities:

2(1) Emulsion stirring facilities;

3(2) Emulsion blending facilities;

4(3) Emulsion filling (packaging) facilities.

1Factories that manufacture pharmaceutical suspensions, tinctures, extracts, fluid extracts or liquid preparations (including eye drops, hemodialysis solutions and lavage solutions) shall, as needed, install the following facilities:

2(1) Facilities for the manufacturing of distilled water distillation or purified water;

3(2) Liquid blending containers, settling tanks or ceramic vats;

4(3) Percolation facilities;

5(4) Soaking facilities;

6(5) Filtration facilities;

7(6) Stirring facilities;

8(7) Quantitative filling (packaging) and container sealing facilities;

9(8) Heat compression (pressure-reduction) facilities;

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1Factories that manufacture pharmaceutical aerosols shall, as needed, install the following facilities:

2(1) Stirring facilities;

3(2) Filling facilities.

1Factories that manufacture pharmaceutical ointments (including eye ointments) or suppositories shall, as needed, install the following facilities:

2(1) Powder grinding facilities;

3(2) Screening facilities;

4(3) Heating vat;

5(4) Blending facilities;

6(5) Filling (packaging) facilities;

7(6) Ointment tube sealing facilities;

8(7) Suppository molding facilities;

9(8) Sterilization, air purification, aseptic filling (packaging) and sterility test facilities;

10(9) Dust collection facilities.

1Factories that manufacture pharmaceutical sticks shall, as needed, install the following facilities:

2(1) Mixing facilities;

3(2) Filling facilities.

1Factories that manufacture pharmaceutical patches shall, as needed, install the following facilities:

2(1) Heating facilities;

3(2) Stirring and kneading facilities;

4(3) Coating facilities;

5(4) Cutting facilities.

1Factories that manufacture pharmaceutical implants shall, as needed, install the following facilities:

2(1) Pressing or molding facilities;

3(2) Sterilization facilities.

1Factories that manufacture injectables (including dialysates) shall, as needed, install the following facilities:

2(1) Facilities for the production of water for injectables;

3(2) Ampoule cutting facilities;

4(3) Container drying, sterilization, cooling and storage facilities; must effectively sterilize containers and prevent contamination;

5(4) Injectable solution filtering facilities; must include cooling element and pathogen filter; for injectables in powder form, this requirement may be waived;

6(5) Filling facilities with precise measuring capabilities;

7(6) Injectables container sealing facilities;

8(7) Sterilization facilities;

9(8) Injectables container seal and leak testing facilities;

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1Factories that manufacture antibiotics shall, as needed, install the following facilities:

21. For injectable antibiotics

3(1) For liquid form antibiotics, the facilities mentioned in preceding one article shall be installed; for power form antibiotics, relevant facilities in Article 16 shall be installed in accordance with actual needs, and aseptic filling (packaging) facilities with appropriate temperature and humidity control capabilities, and automatic or semi-automatic precision scales shall also be installed additionally.

4(2) Doors/windows that open to the exterior shall be double doors/windows that seal tightly.

5(3) There shall be potency and safety testing facilities for antibiotic raw materials and products.

6(4) Preparation rooms (for drying, sterilization and storage of packaging materials and containers, and other preparatory tasks related to packaging) and packaging rooms (with appropriate temperature and humidity control capabilities, and automatic or semi-automatic precision scales) shall be installed in processing and packaging areas.

72. For non-injectable antibiotics (including capsules, tablets, liquids, ointments, etc.): The various types of facilities described in the rules governing each dosage form shall be installed; in processing and packaging areas, air clean and sterilization equipment, and equipment for the regulation of temperature and humidity, shall be installed in accordance with actual needs; furthermore, the facilities mentioned in Item 2 and Item 3 of the preceding Subparagraph shall also be installed.

1Factories that manufacture biopharmaceuticals or biotechnology products shall have operation areas with interior ceilings, walls, doors, floors and other structural components that are easily cleaned and disinfected; and shall also, as needed, install the following facilities:

2(1) Facilities for the breeding and segregation of animals used in manufacturing and testing, and animals that have been inoculated with microorganisms;

3(2) Areas, facilities and equipment for safety testing and bioassaying;

4(3) Factories that collect animal blood or use other animal products in the manufacturing of vaccines shall possess water sources and facilities sufficient for required rinsing.

5(4) Waste water removal and disinfection facilities shall be installed in the operation areas.

6(5) Microorganism culturing facilities;

7(6) Microorganism filtering facilities;

8(7) Microorganism inoculation and collection facilities;

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1Factories that grind Chinese herbal medicines shall, as needed, install the following facilities:

2(1) Pulverizing facilities;

3(2) Screening facilities;

4(3) Drying facilities;

5(4) Dust collection facilities;

6(5) Re-packaging and packaging facilities.

1Factories that concoct sliced Chinese herbal medicines shall, as needed, install the following facilities:

2(1) Sorting and processing facilities;

3(2) Slice processing facilities;

4(3) Slicing facilities;

5(4) Drying facilities;

6(5) Concocting facilities;

7(6) Re-packaging and packaging facilities;

8(7) Other relevant facilities.

1Factories that manufacture Chinese herbal plasters/poultices and adhesive pads shall, as needed, install the following facilities:

2(1) Pulverizing facilities;

3(2) Mixing facilities;

4(3) Paste boiling vat and stirring facilities;

5(4) Plaster coating facilities;

6(5) Cutting facilities.

1Factories that manufacture flaked Chinese herbal medicines shall, as needed, install the following facilities:

2(1) Slicing (mincing) facilities;

3(2) Screening facilities;

4(3) Mixing facilities;

5(4) Drying facilities.

1Factories that manufacture Chinese herbal liquids, essences, liquors, syrups, or jellies shall, as needed, install the following facilities:

2(1) Cutting (mincing) facilities;

3(2) Soaking facilities;

4(3) Filtering facilities;

5(4) Boiling or concentration facilities;

6(5) Distillation facilities;

7(6) Stirring facilities;

8(7) Liquid filling (packaging) facilities;

9(8) Gel casters and gel cutters.

1Factories that manufacture Chinese herbal concentrates shall, as needed, install the following facilities:

2(1) Cutting (mincing) facilities;

3(2) Extracting facilities;

4(3) Filtering facilities;

5(4) Pressure-reducing and concentration facilities;

6(5) Thermostatic or vacuum drying facilities.

1Factories that manufacture hard gelatin capsule shells shall, as needed, install the following facilities:

2(1) Gelatin dissolving facilities;

3(2) Molding facilities;

4(3) Drying facilities;

5(4) Capsule cutting and joining facilities;

6(5) Sterilization and distillation facilities;

7(6) Microorganism testing facilities;

8(7) Operation areas shall be installed with air clean facilities, and facilities for the regulation of temperature and humidity.

1Factories that manufacture medicinal gases shall, as needed, install the following facilities:

2(1) Storage facilities;

3(2) Vaporizing facilities;

4(3) Air compression facilities;

5(4) Purifying facilities;

6(5) Filling facilities;

7(6) Separation facilities;

8(7) Synthesis facilities.

1In factories that manufacture medical materials, operation areas shall be separated based on the type of material produced; they shall also, as needed, install the following facilities:

2(1) Cotton fluffing, spreading or carding machines; where these procedures are contracted out to other factories, installation of said facilities may be waived.

3(2) Pressure degreasing facilities;

4(3) Rinsing facilities;

5(4) Dehydration facilities;

6(5) Drying facilities (drying room);

7(6) Spinning machines, weaving machines and other textile facilities; where these procedures are contracted out to textile factories, installation of said facilities may be waived.

8(7) Gauze cutting facilities;

9(8) Bandage cutting facilities;

1Factories that manufacture syringes shall, as needed, install the following facilities:

2(1) Gas processing facilities;

3(2) Grinding processing facilities;

4(3) Graduation mark facilities;

5(4) Syringe joint inspection facilities;

6(5) Glass alkalinity testing facilities;

7(6) Crack detecting facilities;

8(7) Heat impact testing facilities;

9(8) Standard volume testing facilities;

10(9) Airtight testing facilities.

1Factories that manufacture electric instruments for medical use shall, as needed, install the following facilities:

2(1) Lathes;

3(2) Drilling machines;

4(3) Jacks;

5(4) Grinding machines or grinding wheels;

6(5) Electric facilities of 1/4 horsepower or greater;

7(6) Punching machines;

8(7) Power distribution panel for use in testing;

9(8) Voltage detectors;

10(9) Ohmmeters.

1Factories that manufacture blood collection and blood transfusion devices (that incorporate plastic tubes) shall, as needed, install the following facilities:

2(1) High-speed stirring facilities;

3(2) Stir cooling facilities;

4(3) Plastic pellet facilities;

5(4) High-pressure steam sterilization facilities;

6(5) High-frequency welding facilities;

7(6) Water sterilization facilities;

8(7) Aseptic operation rooms.

1Factories that manufacture hypodermic needles shall, as needed, install the following facilities:

2(1) Straight line facilities;

3(2) Grinding facilities;

4(3) Needle valve seat facilities;

5(4) Tightening facilities;

6(5) Bend testing facilities;

7(6) Flexibility testing devices;

8(7) Pull-out testing devices;

9(8) Pinch meters;

10(9) Microcalipers;

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1Re-packaging, packaging and labeling areas shall, as needed, install the following facilities:

2(1) Weighing instruments and other necessary re-packaging facilities (counting devices, automated re-packaging facilities, etc.)

3(2) Damp-proof packaging facilities;

4(3) Bottle sealing/stopping machines;

5(4) Semi-automatic or automatic ampoule labeling facilities;

6(5) Batch number printing facilities;

7(6) Revolving or regular operation tables.

Facilities at medical device factories shall be installed based on actual manufacturing needs; facilities used in the inspection and testing of products to ensure product compliance shall be appropriately monitored, managed, rectified and maintained.

This set of standards shall be implemented on the date of announcement.