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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 5 Raw Materials and Packaging Materials
Article 32
Raw materials and packaging materials purchased by the cosmetics manufacturer shall meet the acceptance criteria.
The acceptance criteria in the preceding paragraph shall be established based on the finished products quality requirements.
Article 33
Raw materials and packaging materials are purchased from the cosmetics manufacturer shall consider the following requirements:
1. The selection and evaluation of the supplier.
2. The establishments of technical clauses such as type of selection to be conducted, acceptance criteria, measures to take in the case of defect or modification, transport conditions or other related items.
3. Setting of the relations and interactions between the company and supplier such as questionnaire, assistance, and audit or other related items.
Article 34
The receiving of the raw materials and packaging materials of the cosmetics manufacturer shall be regulated as follows:
1. The records of the purchase order, the deliver notes and the receiving materials shall all match.
2. The integrity of the raw materials and packaging materials shall be checked. Transportation data shall be inspected if necessary.
Article 35
The raw materials and packaging materials identification and status in the cosmetics manufacturing premises shall be regulated as follow:
1. Shall be labelled in order to identify the material and batch information.
2. The raw materials and packaging materials shows defects that may affect the product quality shall be suspended hold for further decision.
3. The raw materials and packaging materials shall be identified and separated according to its status, such as accepted, rejected or quarantined. Those can be identified by using physical system of identification or others methods that can ensure the same level of identification.
The identification of the raw materials and packaging materials mentioned in the preceding paragraph shall include the following information:
1. Name of the product indicated on the delivery note.
2. Name of the products given by the company. If different from the name or code number given by the supplier, shall be indicated clearly.
3. Batch reference provided by the supplier and the one given at the receipt shall all be presented if there is any difference.
4. Name of the supplier.
5. Date and number of the receipt, if necessary.
Article 36
The release of the raw materials and packaging materials in the cosmetics manufacturing premises shall be regulate as follows:
1. To establish physical or other alternative system to ensure only released raw materials and packaging materials are used.
2. The release of the raw materials shall be enforced by authorized personnel who are responsible for the quality.
3. The analysis certificates provided by the supplier can be accepted as the acceptance criteria, only if the supplier possess the sufficient technology, experience and knowledge, and agree with the test methods adopted by the company, as well as the appropriate inspection and audit conducted by the company.
After measurement, when there are remaining released raw materials mentioned in the preceding paragraph, they shall be contained in a sealed container, labelled adequately and stored properly in the storage.
Article 37
The storage of the raw materials and packaging materials in the cosmetics manufacturing premises shall be regulated as follows:
1. Storage condition shall be set up properly to fit each raw materials and packaging materials. Monitoring and control measures shall be taken to maintain the specific storage if necessary.
2. The raw materials and packaging materials shall be stored and handled properly according to its characteristics.
3. The container of the raw materials and packaging materials shall be sealed and stored off the floor.
4. When repacking the raw materials and packaging materials, the content on the labels shall be identical to the original labels.
5. When raw materials and packaging materials are rejected or quarantined, they shall be stored at a certain location, or use other methods to ensure they can be identified.
6. To establish measures to ensure stock turnover, and stock rotation shall follow the rules of first in, first out.
7. Periodic inventory shall be performed to ensure the inventory information is correct. Any significant discrepancy shall be investigated and corrected.
Article 38
In order to prevent the misuse of materials after the defined period of storage, the cosmetics manufacturer shall establish a re-evaluation system for those materials to determine the suitability for use.
Article 39
The quality of water used in production shall be regulated as follows:
1. The water treatment system shall supply a defined quality of water.
2. The water quality shall be monitored or verified through water quality testing or process parameters.
3. The water treatment system shall permit sanitation.
4. The material used for the water treatment equipment shall be selected to ensure the water quality is not affected; the settlement of the water treatment equipment shall avoid any water stagnation or the risk of contamination.