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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 2 Management and Personnel
Article 4
The personnel in the cosmetics manufacturing premises shall have an appropriate training to comply the quality of production, control and product storage operation.
Article 5
The personnel in the cosmetics manufacturing premises shall establish the organization according to the following:
1. Regulate the organization and to establish an organization chart to ensure the division of labor and competency according to the scale and diversity of its product of the manufacturing premises.
2. To ensure there are adequate staffing levels and well-trained as well as sufficient personnel in the different scope of activity according to its diversity of products.
3. The quality assurance unit and quality control unit shall be independent to other departments. The responsibility of quality assurance and quality control can be undertaken by a separate quality assurance unit and quality control unit or a single unit accordingly.
Article 6
The cosmetics manufacturing premises shall regulate the key responsibilities as follows:
1. Management level:
(1) The organization shall be supported by the top management of the company to ensure the enforcement of these regulations.
(2) To monitor the participation and commitment of the personnel at all level in the manufacturing premises for the following these regulations.
(3) Management shall categorize the areas in which the authorized personnel are allowed to access.
2. Personnel in each department and each level:
(1) To ensure the position and department in the organizational structure.
(2) To ensure the scope of responsibilities.
(3) To obtain the related documents within the scope of responsibilities, and follow the regulations indicates in the documents.
(4) Comply with personal hygiene requirements according to Article 8.
(5) To report the irregularities and other non-conformities.
(6) To receive adequate educational training and skills to perform the activities and responsibilities.
Article 7
Personnel of the cosmetics manufacturer involved in production, control, storage and shipment shall acquire the appropriate abilities of working experience and training according to the responsibilities.
1. Appropriate training related to the activities in this regulation shall be provided to all personnel.
2. To ensure training needs of different levels and qualification of the personnel, and to conduct and enforce its related training program.
3. The training program shall be considered and developed according to the expertise, experience, and the scope of responsibilities of the personnel.
4. The cosmetics manufacturer may outsource to a professional group, if necessary, to develop and enforce training program according to the training needs and manufacturing premises resources.
5. The personnel shall receive training normally and continually, and the training content and program shall be updated regularly.
6. Newly recruited personnel shall receive theory and practical training related to this regulation, and specific training according to the duties assigned to them.
7. The effectiveness of receiving the training shall be evaluated during the training process or afterwards.
Article 8
The cosmetics manufacturer shall control the hygiene and health of the personnel, and the following regulation shall apply:
1. To establish and to adapt the need of a hygiene program, these requirements shall be understood and followed by all personnel who entered in the production, control and storage area.
2. Personnel shall be instructed to the hand washing facility.
3. Ensure the personnel who enter production, control and storage to wear appropriate clothing and protection outfit to avoid the contamination of cosmetic products.
4. Avoid the personnel from eating, drinking, chewing, smoking, or to store foods, drinks, smoking products or personal drugs in the production, control, and storage area.
5. Prohibit all the unhygienic practice in the production, control, storage area or in any other area where the product may be adversely affected.
6. Any person affected by an apparent illness or having open wound, a measurement shall be taken to be excluded from direct contact to the products until the condition is corrected or determined by medical personnel that the quality of cosmetic products will not be compromised.
Article 9
Visitor or untrained personnel shall be prohibited to enter production, control and storage area. However, if there is any necessity to enter these areas, they shall be given related precaution in advance, including rules about personal hygiene and the prescribed protective clothing, and closely supervised.