T/HNJK 003-2018 Quality Management Standards for the Production of Healthcare Products

Scope

Scope: This standard specifies the terms and definitions, evaluation rules, evaluation content, main indicators, evaluation methods, and evaluation processes for health care products. The term "health care products" as defined in this standard refers to products such as patches, ointments, rubs, sprays, and moxibustion, which are directly or indirectly applied to the human skin surface and are not intended for disease prevention or treatment. They possess daily health care, rehabilitation, and health promotion functions. These products should have been used in folk medicine for a long time, be simple and safe to use, and have the ability to regulate bodily functions, alleviate physical discomfort symptoms, and promote health, suitable for sub-healthy populations for conditioning and health care. Exceptions apply to products regulated by laws and regulations such as drugs, health foods, medical devices, special-purpose cosmetics, disinfection products, and sports equipment. This standard applies to the evaluation and management of health care products for producers, operators, and service providers. This standard applies to the management of health care product production and sales. It sets forth basic technical requirements for enterprise personnel, design and facilities, raw materials, production processes, finished product storage and transportation, as well as quality and hygiene management. Main technical content: 5. Raw materials 5.1 The purchase and use of raw materials required for health care product production shall be subject to inspection, storage, use, and testing systems, and shall be managed by dedicated personnel. 5.2 Raw materials must meet hygiene requirements. The variety, source, specification, and quality of raw materials shall be consistent with the approved formula and product enterprise standards. 5.3 Raw materials must be purchased in accordance with relevant regulations and accompanied by valid testing reports. 5.4 For raw

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