Sanitary Standards for Sanitary Product Manufacturers (2009) Health Quality Management

Article 36 The legal representative (responsible person) or authorized person in charge of the production enterprise shall be responsible for the quality of the product and the implementation of this code.

Sterilizers, skin and mucous membrane disinfectants (except for skin disinfectants for hand washing), chemical (biological) indicators, contact lens care products manufacturers should set up a sanitary quality management department, responsible for the quality management of the whole process of product production.

Other disinfection product manufacturers should set up a full-time and part-time health administrator to be responsible for the quality management of the whole process of product production.

Article 37 Production enterprises shall establish and improve various standard operating procedures and management systems for the production of disinfectant products.

The management system includes: personnel post responsibility system, production personnel personal hygiene system, equipment procurement and maintenance system, health quality inspection system, sample retention system, material procurement system, raw material and finished product storage management system, sales registration system, product complaints and handling system. , unqualified product recalls and their handling systems.

Article 38 When a production enterprise produces different products of the same process on the same production line, it shall formulate operating procedures, cleaning and disinfection operation procedures and clearing operation procedures for production equipment and containers.

Article 39 A production enterprise shall establish and record various records of the production process, including material procurement acceptance records, equipment use records, batch production records, batch inspection records, and sample records.

All records should be complete, to ensure traceability, disinfection and sanitation products clean workshop planning and construction, not to be arbitrarily altered, wet wipes disinfection sanitary products clean workshop, properly preserved to 3 months after the product validity period.

Article 40 A production enterprise shall establish a sanitary quality inspection room that is compatible with its production capacity and product self-inspection requirements in accordance with the requirements of this code. Set up physical and chemical and/or microbiological testing rooms according to product characteristics and factory inspection items.

The microbiological laboratory shall comply with the relevant requirements set by the laboratory, disinfect the sanitary product clean workshop, and meet the needs of the factory inspection project.

Instruments and instruments with special requirements should be placed in a special instrument room. The indoor temperature, relative humidity, static electricity, vibration and other environmental factors should meet the special requirements of the instrument.

Article 41 The detection of the active ingredient content of disinfectant and anti-bacterial preparations requires the use of instruments such as gas chromatography and high-performance liquid chromatography, and may be entrusted to the inspection by a metrologically certified inspection agency.