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Laws & Regulations Database of The Republic of China (Taiwan)

Print Time:2024/11/24 13:07
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Chapter Law Content

Title: Cosmetics Good Manufacturing Practice Regulations CH
Category: Ministry of Health and Welfare(衛生福利部)
Chapter 3 Premises and Facilities
Article 10
The location, design, construction, and use of the cosmetics manufacturing premises shall be regulated as follows:
1. To make sure the produces are protected.
2. May enforce effective cleaning. Sanitizing and maintenance shall be enforced when necessary.
3. To minimize the risk and control of mix-up of products, raw materials, and packaging materials.
The design of the premises mentioned in the preceding paragraph shall consider the type of the cosmetic product produced, existing condition, cleaning, sanitizing, and other necessary measures.
Article 11
The storage, production, quality control, ancillary, washing and toilets of the cosmetics manufacturing premises shall be separated of identified clearly.
Article 12
There shall be sufficient space to enforce operations such as receiving, storage, production or other related operations in the cosmetics manufacturing premises.
Article 13
The flow of the materials, products, and personnel through the building or between the buildings shall be planned properly to avoid any mix-ups in the cosmetics manufacturing premises.
Article 14
The design and construction of the cosmetics manufacturing premises shall be regulated as follows:
1. The design and construction of floors, walls, ceilings and windows of the production area, shall be implemented with smooth surfaces to tolerate cleaning agents and sanitizers. They shall be easy to clean and sanitized to maintain in a good condition.
2. The windows shall be non-opening design, except if there is insufficient ventilation in the buildings, shall set up with push out casement windows with screens.
Article 15
Sufficient and clean washing and toilet facilities shall be provided in the cosmetics manufacturing premises. The facilities shall be separated from production area. Sufficient shower and clothes changing facilities shall be provided when necessary.
Article 16
The lighting of the cosmetics manufacturing premises shall be regulated as follows:
1. Sufficient lighting facilities shall be installed to provide the needs for operation.
2. The lighting facilities shall be installed properly or other measures be taken to make sure there will not be any fragments from potential breakage to contaminate the products.
Article 17
There shall be sufficient ventilation, or other specific measures to be taken to protect the products in the cosmetics manufacturing premises alternatively.
Article 18
The pipework, drains and ducts in the cosmetics manufacturing premises shall be regulated as follows:
1. Shall be installed properly to avoid any drip and condensation to contaminate the materials, products, equipment, and facilities.
2. Drains shall be kept flowing smoothly and without any back flow.
3. Exposed overhead rood beams, pipes and ducts shall be avoided. Exposed pipes shall be suspended by brackets or separated and not touch the walls for easy cleaning.
4. Specific measures to be taken to protect the products when necessary.
Article 19
The cleaning and sanitation of the facilities of the cosmetics manufacturing premises shall be regulated as follows:
1. To conduct a specific cleaning and sanitation plan for each area, and to keep it in a clean condition.
2. To enforce cleaning and necessary sanitation to ensure the products are not contaminated.
3. To identify the specific kinds of the cleaning agents and sanitizers, and to ensure they work effectively.
Article 20
The cosmetics manufacturing premises and facilities shall be repaired and maintained properly.
Article 21
The cleaning agents and lubricants cosmetics manufacturer used to clean, sanitize or maintain premises and facilities shall not affect the quality of the products.
Article 22
The pest control in the cosmetics manufacturing premises shall be regulated as follows:
1. The design, construction, and maintenance of the premises shall be effective to avoid any insects, birds, pests, rodents and other vermin.
2. A pest control plan shall be conducted.
3. Measures shall be taken to prevent attracting pests at the exterior of the premises.
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