T/KYXZ 03-2024 Gelatinous health care product production technical specifications

Scope

Scope: This standard specifies the terms and definitions, formulation requirements, production processes, physical characteristics, product identification, inspection methods, marking, labeling, packaging, transportation, and storage for the production of adhesive plaster health products. This standard applies to the production of adhesive plaster health products. Main technical content: 4. Formulation requirements 4.1 The formulation shall clearly specify the origin of the raw materials. For those raw materials not listed in the Pharmacopoeia of the People's Republic of China, official publication materials shall be provided as proof. 4.2 Products of the same specification from the same batch, produced by the same shift and on the same production line, shall be considered as a batch. 4.3 The formulation shall clearly specify the names and dosages of raw materials and excipients. 4.4 For raw materials and excipients that undergo special processing before formulation, the processing methods shall be indicated. 4.5 Auxiliary materials shall comply with the requirements of FZT64005-2021 for Hygienic Thin Nonwoven Fabrics. 5. Production processes 5.1 Describe the key process steps, including the processing methods of raw materials and excipients, the preparation process of filler fineness, technical parameters, wrapping methods, and packaging. 5.2 A description of the product specifications of adhesive plasters shall be provided. 5.3 A description of the material properties of the pharmaceutical backing substrate shall be provided. 6. Physical characteristics Describe the appearance of the product, including no visible dirt or stains, no specific odor of traditional Chinese medicine, the softness and hardness of the cloth-wrapped adhesive plaster, its shape and size, and its color. 7. Identification For adhesive plaster health products made from more than three ingredients, at least one main raw material shall be subject to thin-layer chromatography identification.

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