T/KYXZ 01-2024 Production specifications for topical health care products

Scope

Scope: This standard specifies the terms and definitions, formulation requirements, production processes, product attributes, identification, technical indicators, testing, usage methods, health benefits, important notes, packaging and labeling, transportation and storage, and basic requirements for shelf life of smear-type health care products. This standard applies to the production of smear-type (spraying, scrubbing, bathing, etc.) health care products; Main technical content: 4. Formulation requirements 4.1 The formulation shall clearly specify the origin of raw materials, and the auxiliary materials shall comply with the relevant provisions of Part I, Part II, and Part IV of the Pharmacopoeia of the People's Republic of China 2020 Edition. For raw and auxiliary materials not included in the Pharmacopoeia, they shall comply with the provisions of national standards, industry standards, or local standards. For those raw and auxiliary materials without corresponding standards, official published literature or detailed descriptions must be provided. It is strictly prohibited to use protected animals and plants as raw and auxiliary materials. 4.2 Products of the same specification from the same batch, the same shift, and the same production line shall be considered as one batch. The formulation shall clearly specify the names and dosages of raw and auxiliary materials, and the minimum dosage shall be calculated based on 1000mL (g). 4.3 For raw and auxiliary materials that undergo special processing before formulation, the processing methods shall be indicated. 4.4 The properties and names of auxiliary materials (such as ethanol, water, oil, vinegar, etc.) shall be marked. 5. Production process: Key descriptions of the preparation process, process parameters, and the names and properties of packaging materials, as well as filling specifications. 6. Product attributes: Description of the appearance and odor of the contents. 7. Identification: 7.1 Microscopic iden

Development Information

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