Second, the scope of application This general rule applies to the production of food additives production license review.
III. Work Requirements (1) The staff engaged in the examination of production licenses shall abide by the relevant laws, regulations, rules and regulations of the General Regulations, administrate them in accordance with the law, enforce the law impartially, and refrain from ignoring private circumstances, and may not solicit or accept the property of the company or seek any other benefits. (2) Before the field verification is carried out, the verification team shall prepare inspection work documents and communicate with the enterprises on matters related to field verification. (3) The on-site inspection shall be conducted in the state of production and operation of the enterprise. (4) Field inspections can be conducted by viewing the site, viewing documents and records, inspecting the on-site operation of relevant personnel, and testing the employees of the enterprise. (5) The terms marked with an asterisk may not apply to certain products, and the verification team shall decide whether this option serves as a verification content in accordance with relevant regulations. If it does not apply, you should select "This item is not applicable" in the form and explain the reason. (6) The field verification system adopts a score system with a score of 150 points and a total score of less than 133 points. (7) The verification team shall fill out the "Verification Record of Food Additive Production Licensing on the Spot" (see attached table) based on the actual verification, and there shall be no blank item in the field inspection record. When necessary, additional pages may be added, and the state of production conditions at the time of the company's on-site inspection may be described by means of images or videos. Information such as field verification records and attached pages shall be signed and verified by the inspection team leader and the person in charge of the company. If the inspection personnel have different opinions, they should sign it together. The relevant personnel of the enterprise have the right to supervise the whole process of on-site verification and provide feedback. (8) Enterprises that are qualified for on-site inspection shall sample and seal the products that enterprises apply for production according to relevant regulations. (9) Sampling methods shall be implemented in accordance with national or industrial standards. If the standard does not specify, it shall be sampled in accordance with the following rules: 1. Sampling shall be randomly selected from products that have been inspected by the enterprise. 2. The sampling quantity should meet the actual inspection needs. Each sample is divided into two averages after mixing, one for inspection and one for inspection by the inspection agency. Samples for inspection and samples for inspection should be guaranteed to be the same batch of products. 3. The company shall set aside more than 10 times the number of samples for sampling. (10) If a national or industrial standard stipulates a quality grade, the product with the highest quality grade in the product application shall be selected. (11) When there is a test item that is compared with the standard in the national or industrial standards, the company should also provide the sample of the same type of product (special circumstances should be specified on the sample). (12) When sampling, it should be noted that the outer packaging of the sample is intact. (13) If the number of sampled samples is not enough or the sample cannot be sampled, it shall be treated as unqualified on site. (14) Where sampling tools and sample containers are required, the enterprise shall prepare clean sampling tools and vials in advance to prevent contamination of the samples. (15) The inspectors sample the sample after sampling and fill in the sample. Seals should have on-site verification of organizational seal, sampler's signature, and date of closure. Enterprise staff should confirm and sign the seal, and affix the company's official seal. When filling out the sampling form, neat handwriting and writing specifications are required. (16) After sealing the sample, the inspector shall inform the enterprise to log on to the website of the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) to inquire about the directory of the production license inspection agency, and the enterprise shall independently select the inspection agency to submit the inspection. The inspector shall not expressly or implied that the company goes to its designated inspection agency for inspection. (17) The enterprise shall send (send) the sample to the inspection agency within 7 working days from the date of sealing. Send (send) the process to prevent damage to the sample, seal damage. Enterprises should fully consider the shelf life of the sample and determine the sample delivery time. (18) When the inspection agency receives the sample, it shall be examined carefully. Those who meet the regulations shall be accepted; if the seals are incomplete, the sampling form is not clearly written out, the samples are damaged or deteriorated, etc., they shall be refused to receive and notify the enterprise on the spot, and shall also notify the examination department. For samples received or rejected, the inspection agency shall sign the seal on the sample and make records. (19) The inspection agency shall keep the received samples properly. The inspection agency shall inspect the samples according to the inspection standards within the warranty period and complete the inspection within 30 working days. Within 2 days after the completion of the inspection, the inspection agency shall submit the inspection report to the organization's examination department and the company.
The medical Psa Oxygen Generator system consists of the air compressor, air-water separation device, dryer, air dew point monitoring device, multi-stage filter, air buffer tank, air moisture monitoring device, oxygen generator, oxygen buffer tank, flow meter, online oxygen monitoring device, cylinder manifold system, smart electric control cabinet, computer monitoring system, remote network monitoring system and optional oxygen booster system.
ETR oxygen generator can produce medical level oxygen with 93%Â±3% purity and 4bar pressure. The oxygen production capacity for single oxygen generator is 3-100Nm3/h.
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