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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 1 General Provisions
Article 1
These regulations are formulated in accordance with the Paragraph 4, Article 8 of the Cosmetic Hygiene and Safety Act (hereinafter referred to as the Act).
These regulations are formulated in reference to the ISO 22716: Cosmetics-Good manufacturing practices (GMP)-Guidelines on good manufacturing practices issued by International Organization Standardization.
Article 2
The definition of terms used in this regulation are defined as follows:
1. Acceptance criteria: the acceptable amount, range, or other suitable measurement methods according to the test result.
2. Auditing: systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives.
3. Batch: the certain produce amount of raw materials, packaging materials, or products from a single or series of manufacturing process.
4. Batch number: The identification of certain batch of products which contains numbers, alphabets, or symbolic combinations.
5. Bulk product: any product that is completed the manufacturing process, but without the final packaging process.
6. Calibration: Under a certain condition, to establish the operation methods and procedures with the known standard reference values to ensure the result values and material testing values of the measurement equipment or measurement system.
7. Control: verification that acceptance criteria are met.
8. Change control: To ensure all manufacturing, packaging, process control and storage of the products to meet the defined acceptance criteria. The amendment plan conducted by the internal organizations and responsible units related to good manufacturing practice.
9. Cleaning: all operations that ensure a level of cleanliness and appearance, consisting of separating and eliminating generally visible dirt from a surface by means of the following combined factors, in variable proportions, such as chemical action, mechanical action, temperature, duration of application.
10. Complaint: external information claiming a product does not meet the defined acceptance criteria.
11. Contamination: occurrence of any undesirable matter such as chemical, physical and/or microbiological matter in the product.
12. Consumables: materials such as cleaning agents and lubricants that are used up during cleaning, sanitization or maintenance operations.
13. Contract acceptor: person, company or external organization to enforce an operation on behalf of another person, company or organization.
14. Deviation: internal organization and responsibilities relative to the authorization to deviate from specified requirements due to a planned or unplanned and, in any case, temporary situation concerning one or several activities covered by the Good Manufacturing Practices.
15. Finished product: cosmetic product that has undergone all stages of production, including packaging in its final container, for shipment.
16. In-process control: controls performed during production in order to monitor and, if appropriate, to adjust the process to ensure that the product meets the defined acceptance criteria.
17. Internal audit: systematic and independent examination made by competent personnel inside the company, the aim of which is to determine whether activities covered by these guidelines and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable for achieving objectives.
18. Major equipment: equipment specified in production and laboratory documents, which is considered essential to the process.
19. Maintenance: any periodic or unplanned support and verification operations designed to keep premises and equipment in proper working condition.
20. Manufacturing operation: set of operations from the weighing of raw materials to the making of the bulk products.
21. Out-of-specification: examination, measurement or test result that does not comply with the defined acceptance criteria.
22. Packaging operation: all packaging steps including filling and labeling, which a bulk product has to undergo in order to become a finished product.
23. Packaging material: any material employed in the packaging of a cosmetic product, excluding any outer packaging used for transportation. Packaging materials are referred to as primary or secondary according to whether or not they are intended to be in direct contact with the product.
24. Plant: location for production of cosmetic products.
25. Premises and Facilities: physical location, buildings and supporting structures used to conduct receipt, storage, manufacturing, packaging, control and shipment of product, raw materials and packaging materials.
26. Production: manufacturing and packaging operations.
27. Quality assurance: all those planned and systematic activities necessary to provide confidence that a product satisfies the defined acceptance criteria.
28. Raw material: any substance going into or involved in the manufacturing of a bulk product.
29. Recall: decision made by a company to call back a product batch that has been put on the market.
30. Reprocessing: re-treatment of all or part of a batch of finished product or a bulk product of an unacceptable quality from a defined stage of production so that its quality may be rendered acceptable by one or more additional operations.
31. Return: sending finished cosmetic products which may or may not present quality defect back to manufacturing premises.
32. Sample: one or more representative elements selected from a set to obtain information about that set.
33. Sampling: set of operations relating to the taking and preparation of samples.
34. Sanitization: operation, used to reduce undesirable micro-organisms on inert contaminated surfaces depending on the objectives set.
35. Shipment: set of operations relative to the preparation of an order and its putting in a transport vehicle.
36. Waste: any residue of a production operation, transformation or use, any substance, material, product that its holder intends for disposal.
Article 3
The cosmetics manufacturing premises shall be regulated according to the public announced cosmetics categories listed in Paragraph 2 Article 8 of the Act.