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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 8 Quality Control Laboratory
Article 50
Quality control laboratory shall apply mutatis mutandis to regulations of Chapter 2 Management and Personnel, Chapter 3 Premises and Facilities, Chapter 4 Equipment, Chapter 11 Contracting, Chapter 16 Documentation.
Quality control laboratory mentioned in the preceding paragraph shall enforce sampling and testing to the cosmetics materials and the finished products. When conducting sampling, testing or other related activities, related control shall be enforced in order to make sure the materials for use complies with the defined acceptance criteria. Packaging and shipping may be approved when the finished products are complying with the defined acceptance criteria.
Article 51
The test methods mentioned in Paragraph 2 of the preceding article shall be clear, appropriate and workable.
The acceptance criteria mentioned in Paragraph 2 of the preceding article shall be defined and established according to types the raw materials, packaging materials, bulk products, and finished products from Quality control laboratory.
Article 52
Test results conducted from quality control laboratory mentioned in the preceding 2 articles shall be reviewed. Decisions of approval shall be made when results complies with the relevant provisions after review; However, rejection or pending shall be made when results does not complies with the relevant provisions after review according to the rules regulated in Article 53.
Article 53
Out-of-specification shall be regulate as follows:
1. Out-of-specification results shall be reviewed and investigated properly by the responsible personnel. Re-testing shall not be performed except with a sufficient and legitimate reason.
2. After the review mentioned in the preceding subparagraph, the decisions shall be made according to the previous article after reviewed as deviation or not.
Article 54
Reagents, solutions, reference standards and culture media shall, at least, be labelled identification information such as name and opening date. If necessary, shall include strength or concentration, storage condition, expiration date, and the name or signature of the person who prepared.
Article 55
The cosmetics manufacturing premises shall perform sampling operation by authorized personnel according to the established sampling operation plan.
The operation plan mentioned in the preceding paragraph shall include the following:
1. Sampling methods.
2. Equipment to be used.
3. Number of the samples.
4. Any precautions to be observed to avoid samples from contamination and deterioration.
5. Identification information of sample.
6. Sampling frequency.
Article 56
Identification information of sample mentioned in Subparagraph 5 of Paragraph 2 of the preceding article shall include the following:
1. Name or identification code.
2. Batch number.
3. Sampling date.
4. The container from which the sample was taken.
5. The sampling point, if applicable.
Article 57
The retention sample shall be regulated as follows:
1. The sample of the finished products shall be retained properly in a specific area.
2. The amount of the retain samples of the finished products shall be sufficient enough to enforce analysis.
3. The samples of the finished products shall be retained with the complete packaging, and retain for an appropriate period according to the storage condition.
4. The samples of the raw materials shall be retained according to the regulations of the manufacturing premises or other relevant regulations.