(ii) equipment selection and material installation (drug GMP implementation and certification P168)(for pharmaceutical companies)
Article 31 the design, selection and installation of equipment shall conform to the requirements of production, be easy to clean, disinfect or sterilize, facilitate production operation and maintenance, and prevent errors and reduce pollution.
Article 32 the surface of equipment in direct contact with drugs shall be smooth, flat, easy to clean or disinfect, corrosion resistant and free from chemical changes or adsorption of drugs.Lubricants and coolants used in equipment shall not contaminate drugs or containers.
Article 33 the name and direction of materials in the main fixed pipelines connected to the equipment shall be marked.
Article 34 preparation, storage and distribution of purified and injected water shall prevent the breeding and contamination of microorganisms.Materials used in storage tanks and pipelines shall be non-toxic and corrosion resistant.Pipe design and installation should avoid dead Angle, blind pipe storage tank and pipe to specify the cleaning, sterilization cycle.The vent port of the wfi storage tank shall be equipped with a hydrophobic bacteria removal filter that does not shed fiber.Injection water storage can use heat preservation, 80 ° C above 80 ° C above thermal cycle or 4 ° C under storage.
Article 35 the scope and precision of the instruments, instruments, measuring instruments and weighing instruments used for production and inspection shall conform to the requirements of production and inspection, be clearly marked as qualified and be checked periodically.
Article 36 the production equipment shall have obvious status signs and shall be regularly repaired, maintained and verified.The operation of equipment installation, maintenance and maintenance shall not affect the quality of products.Unqualified equipment should be moved out of the production area if possible, there should be obvious signs before moving out.
Article 37 all production and inspection equipment shall have records of use, repair and maintenance, which shall be managed by special personnel.