T/HNJK 002-2019 Healthcare product production quality management specification

Scope

Scope: Health care products refer to patches, ointments, rubbing agents, sprays, moxibustion, and other products that directly or indirectly act on the surface of the human skin, not for the purpose of preventing and treating diseases, but for daily health care, promoting recovery, and enhancing health. They are products that have been used in folk medicine for a long time, with simple methods, safety and effectiveness, and the functions of regulating bodily functions, alleviating physical discomfort symptoms, and promoting health, suitable for sub-healthy people to use for conditioning and health care. Except as otherwise provided by laws and regulations for 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. Main technical contents: 1. Preface------------------------------------------------------------------------------------ 2. Scope------------------------------------------------------------------------------------ 3. Normative reference documents---------------------------------------------------- 4. Personnel------------------------------------------------------------------------------------ 5. Design and facilities---------------------------------------------------- 6. Raw materials---------------------------------------------------- 7. Production process---------------------------------------------------- 8. Evaluation and recognition---------------------------------------------------- 9. Finished product storage and transportation---------------------------------------------------- 10. Quality management----------------------------------------------------

Development Information

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