化妆品製造工厂设厂标准 ( 中国台北 )

Transcription

1 Standards for Cosmetics Manufactories (Chinese Taipei) 化妆品製造工厂设厂标准 ( 中国台北 ) Food and Drug Administration of Taiwan (FDA) Compiled by Chemlinked Release Date 2008/04/30 Implementation Date 2008/04/30

2 Disclaimer This is an unofficial document provided by ChemLinked (chemlinke( ed.com/en/), a division of REACH24H Consulting Group, as an informational service to assistt non-chinese companies. This document should only be usedd as a reference and inn case of any discrepancy between the English and Chinese versions the original Chinese version shall prevail. ChemLinked is a unique portal to must-know Asia Pacific Chemical, Cosmetic, Food, Agrochemical regulatory issues. Nondisclosure: You may not disclose this documentt to anyone else without the written permission of ChemLinked. For further clarification and questions, please contact us: contact@chemlinked.comm

3 Standards for Cosmeticss Manufactories Article 1 This set of standards is formulated in accordance with regulations of Paragraph 5, Article 15 of the Statute for Control of Cosmetic Hygiene. Article 2 Cosmetics manufactories shall comply with the following basic requirements and be provided with common equipment: : 1. Manufactories shall be separatedd from residential or public p area and may not interfere with public health or safety. 2. Manufactory buildings shall be solid and clean, and designed to prevent rodents, insects and dust; interiorr ceilings, walls and floors shall be smoothh and free of cracks and crevices, easy to clean, and non-conducive to the collection of dust (e.g. utilizing materials such as epoy resins that are easily disinfected and cleaned); Interior pipelines shall utilize materials with smooth surfaces and minimize the visibility; drainage systems shall have outlets with sewage reflu prevention functions. 3. Operation areas shall be clearly delineated (e.g. the liquid form preparation manufacturing room, the powder form preparation manufacturing room, the packaging room, the warehouse and other relevant areas). 4. Storage areas of raw materials, supplies, semi-finished productss and finished products may be appropriately separated according to manufacture ers need. 5. There shall be container-washingg equipment. 6. All containers and manufacturingg equipment in manufactories shall utilize stainless steel, anodized aluminum, non-toic plastic orr other water-tolerantt materials where necessary; lead, iron, copper, and other toic chemical materials are forbidden to be utilized. 7. There shall be weighing equipment complying with regulations and being calibrated regularly. 8. There shall be locker rooms r and hand-washing facilities for employers, and facilities for washing or sterilization n of work clothes, caps, face masks, gloves and

4 shoes. 9. Boilers, water pumps, vacuum pumps, compressors, general-useg e-water treatment systems, equipment for water distillation or purification, equipment for dust removal, air ventilating or air cleaning and sterilization, or air,, temperature and moisture control facilities shall be installed as needed. 10. Operations, such as production, processing, or packaging, shall be conducted by relevant facilities in manufactories in an integrated closed systemm from the inlet to the outlet of materials, in principle. Operations without being conducted in an integrated close system and involving in causing powderr or toic gas shall be conducted where independent ventilators installed and in negative pressure. 11. There shall be Bates numbering machines for direct printing p of batch numbers and manufacture date off products. Article 3 Cosmetics manufactories producing powder form products shall install the following equipment: 1. Powder milling or ultra-fine powder milling equipment. 2. Screening and dust collecting equipment. 3. Miing equipment. 4. Quantitative filling (packaging) equipment. Manufactories in the preceding Paragraph may, as needed, install drying machines or drying ovens. Article 4 Cosmetics manufactories producing liquid form products shall install the following equipment: 1. Liquid blending containers, settling tanks or ceramic vats. v 2. Stirring equipment. 3. Filtrating equipment. 4. Quantitative filling (packaging) equipment. Manufactories in the preceding Paragraph may, as needed, install the following equipment: 1. Heat compression (pressure-reduction) equipment. 2. Autoclave sterilization equipment.

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