20 Common Purified Water Equipment System GMP Verification Questions - Water Purification Related - Purified Water Equipment System GMP

After the introduction of the new version of GMP certification, many pharmaceutical companies will encounter some problems in the GMP certification of purified water pharma machinery systems. 1. The PID diagram is not installed on the purified water equipment; 2. The sampling point number is not attached to the pure water pharma machinery; 3. The water point number needs to be added to the purified water system; there is no flow direction mark on the pipeline above the purified water storage tank; 4. The physical and chemical detection of the purified water In the record: there is no original printed record for the measurement of non-volatile matter; the measurement of electrical conductivity should be added to the unit; the entire record is too coarse and the operability is not strong; Pipelines, valves, water supply pumps, and pressure gauges are not made according to the standard of purified water, and there is a risk of pollution; 6. The operation of the automatic solenoid valve is not verified during the verification of the purified water system; 7. Install the online conductivity of purified water There are no drawings during monitoring; 8. There is no management design drawing for the purified water, the pipelines are not hygienically connected, and there is no daily monitoring, and the pipeline design is not conducive to sampling; 9. The purified water irrigation and welding do not meet the requirements, and the forming process of one side welding and two sides should be adopted. , and provide endoscopic photos of the purified water pipeline; 10. There is no sampling record in the purified water equipment system; a flow meter should be installed at the purified water return; 11. The purified water system needs to 12. Validation of purified water system, IQ, OQ, PQ and other performance of purified water pharma machinery system are verified; 13. Design, installation and ozone disinfection of purified water Parts such as basis, welding, verification and confirmation do not meet the requirements; 14. The drawings of purified water equipment do not match the actual design, and each control valve should be marked on the drawings; 15. Problems with pipes, water storage tanks, and electric welding; 16. Reserve out There should be a thermometer at the water outlet and the water return port to control the temperature change, and there should be a flow monitor; 17. The connection method of the purified water pipeline interface should adopt the connection method of sanitary clamp, and the use of the wire tooth connection method should be avoided; 18. Purification The pipeline in the water section should adopt automatic welding process and professional pipe cutting tools; 19. The installation of the circulating pipeline has no slope, and the lowest point is not designed as the discharge point; 20. There is a dead angle in the purified water system pipeline, which is easy to breed microorganisms and bacteria.
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