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

Print Time:2024/11/22 05:32
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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 4 Equipment
Article 23
Equipment in the cosmetics manufacturing premises shall meets the intended uses, and easy to clean, sanitize, and maintain if necessary.
Article 24
The equipment design in the cosmetics manufacturing premise shall meet the requirements as follows:
1. The production equipment shall be designed to prevent the products from being contaminated.
2. The container for bulk products shall come with the protection to avoid dusts, moisture and other air contaminants.
3. Transfer hoses and accessories shall be cleaned and sanitized if necessary, kept dry and protected properly from dusts, splash or other contamination.
4. The material of the equipment shall be compatible with the products, cleaning agents, and sanitizer.
Article 25
The installation of the equipment shall be regulated as follows:
1. The design and installation of the equipment shall be easy to drain in order to clean and sanitize.
2. The placement for the equipment shall consider the movement of materials, movement of mobile equipment, and personnel flow, not to pose a risk to the quality.
3. Appropriate access space under, inside and around the equipment shall be provided for cleaning and sanitizing.
4. The major equipment shall be easy to identify.
Article 26
The equipment calibration in the cosmetics manufacturing premises shall be regulated as follows:
1. Laboratory and production measuring instruments related to production quality shall be calibrated regularly.
2. If calibration results of measuring instruments do not meet the acceptance criteria, those shall be identified specifically and removed from service.
3. The condition set forth in the preceding subparagraph shall be investigated to confirm the impact to the production quality and to take appropriate measures afterwards according to the investigation result.
Article 27
The cleaning and sanitation of the equipment in the cosmetics manufacturing premises shall be regulated as follows:
1. All equipment shall be cleaned adequately. A Sanitation plan shall be established if necessary.
2. Cleaning agents and sanitizers shall be specifically identified and work effectively.
3. Where equipment is assigned for continuous production or production of successive batches of the same products, that equipment shall be cleaned and if necessary, a sanitizing period can be established to carry out.
Article 28
The equipment maintenance of the cosmetics manufacturing premises shall be regulated as follows:
1. The equipment shall be maintained regularly.
2. Maintenance operation shall not affect the quality of the products.
3. The defective equipment shall be identified accordingly and excluded from use and isolated, except for any unavoidable condition.
Article 29
The consumable uses for equipment in the cosmetics manufacturing premises shall not affect the quality of the products.
Article 30
The equipment or automated system in the cosmetics manufacturing premises used in production and control shall be access and used by authorized personnel.
Article 31
The cosmetics manufacturer shall prepare an adequate alternative back-up plan for operation system breakdown or failure.
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