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

Print Time:2024/11/22 06:13
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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 6 Production
Article 40
At each stage of manufacturing production, measures shall be taken to ensure the finished products meet the defined specification.
Article 41
The cosmetics manufacturer, according to the need of every manufacture operation stage, relevant documents and data shall be prepared and available. The documents are:
1. Equipment documents.
2. Formula for the products
3. List of all raw material with the quantities and identified batch numbers.
4. Detailed manufacturing process for each stage, including the addition of the raw materials, temperature, speeds, mixing time, sampling, cleaning, necessary sanitizing, transfer of bulk products and other related items.
Before starting any manufacturing process mentioned in the preceding paragraph, these items have to be ensure:
1. All the relevant documents related to manufacturing and all raw materials are prepared, available and released.
2. Equipment is able to use properly and has been through appropriate cleaning and sanitizing.
3. Operation area is cleaned to prevent from mixing any materials from the previous manufacturing operations.
The identification of the manufacturing operation mentioned in paragraph 1 shall be regulated as follows:
1. All raw materials measured and weighted according to the formula, and placed in a labelled, cleaned and suitable container, or directly put into the manufacturing equipment.
2. Major equipment, raw material containers, and bulk product containers shall be identified easily at any time.
3. The identification on the bulk product container shall include: Name or identification code, batch number and storage condition when such information is critical to assure the quality of the products.
Manufacturing process mentioned in the preceding paragraph shall be regulated as follows:
1. Establish a manufacturing process control plan includes acceptance criteria and to enforce it.
2. To enforce the plan mentioned in the preceding sub-paragraph. Any result does not meet the acceptance criteria shall be and reported and investigated according to the procedure.
Article 42
Every batch of manufactured bulk products shall be assigned a batch number. When the batch number is different from the numbers on the finished products, it shall be easy to identified and related to each other.
The storage of the bulk products mentioned in the preceding paragraph shall be regulated as follows:
1. Use the proper container for to store, and to place it at a specific location with adequate condition.
2. Set up a defined period of storage.
3. Bulk products shall be re-evaluated and not allowed to use when passed the defined period of storage.
Article 43
The cosmetics manufacturer, According to the needs for every stage of packaging operations, the following relevant documentations and data shall be available:
1. Equipment documents.
2. Lists of packaging materials.
3. Operation details in every stages including filling, sealing, labeling, coding or other items.
Before starting any packaging operation mentioned in the preceding paragraph, it shall be ensure that:
1. Prepare the documentations and data listed in the preceding paragraph.
2. Equipment is able to use properly and has been through appropriate cleaning and sanitizing.
3. Operation area is cleaned to prevent from mixing any materials from the previous manufacturing operations.
4. Finishing the establishment of the numbering for product identification information.
Every batch of manufactured bulk products shall be assigned a batch number. When the batch number is different from the numbers on the finished products, it shall be easy to identified and related to each other.
During the packaging operation, according to the actual process, Identification information shall be placed on each operation line; the information includes:
1. Name and identification code of the packaging operation line.
2. Name and identification code of the finished products.
3. Batch number.
The unused packaging materials shall be placed in a sealed container and labelled properly. Then it can be restored to the storage.
When filling and labelling operation does not complete at once, measures such as quarantine and identification shall be taken to avoid mix-up or mislabeling.
Article 44
The packaging mentioned in the preceding article, the in-process control shall be regulated as follows:
1. To establish an in-process control plan including acceptance criteria, and to enforce it.
2. Any result does not meet the acceptance criteria shall be and reported and investigated according to the procedure.
The control mentioned in the preceding paragraph, including those who use on-line control equipment shall be checked regularly according to the established period, items and content.
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