After the release of the new GMP certification, many pharmaceutical companies will encounter some problems in the GMP certification of medical purified water equipment systems. The following are 20 common GMP certification issues for pharmaceutical medical purified water equipment systems collected by the Water Treatment Home Network.
1. There is no PID chart installed for medical purified water equipment.
2. The sampling point number is not affixed to the pure water equipment.
3. The water point number needs to be added to the purified water system; there is no flow direction identification on the pipeline above the purified water storage tank;
4. In the physical and chemical test records of purified water: there is no original print record for non-volatile matter detection and weighing; the unit for conductivity measurement should be added; the entire record is too thick and the operability is not strong.
5. Purified water system is purified water from the EDI, but the pipelines and valves, water pumps, and pressure gauges on site are not installed according to the purified water standards, and there is a risk of contamination.
6. During the verification of the purified water system, the operation of the automatic solenoid valve was not verified to be correct.
7. There is no drawing when installing purified water online conductivity monitoring.
8. There is no management design drawing for purified water, the pipeline is not sanitary, and there is no daily monitoring. The pipeline design is not conducive to sampling.
9. Purified water irrigation and welding do not meet the requirements, and one side welding and two sides molding process should be used, and an endoscope photo of the purified water pipeline should be provided.
10. There is no sampling record for medical purified water equipment system; a flow meter should be installed at the return water of purified water.
11. Purified water system requires weekly inspection of total delivery, total return, storage tanks, and water points, and the remaining water points are inspected monthly.
12. Validation of purified water system, verify the IQ \ CQ \ DQ performance of medical purified water equipment system.
13. The design, installation, ozone disinfection basis, welding, verification and other parts of the purified water do not meet the requirements.
14. The drawings of medical purified water equipment are inconsistent with the actual design, and each control valve should be indicated on the drawings.
15. Problems with pipes, water storage tanks and electric welding.
16. There should be a thermometer at the reserve water outlet and return water outlet to control its temperature change, and there should be a flow monitor.
17. The connection method of the purified water pipe interface should be sanitary clamp connection method, and the use of wire connection method should be avoided.
18. Purified water section pipeline should adopt automatic welding process and professional pipe cutting tools.
19. Circulation pipeline installation has no slope, and the undesigned low point is the discharge point.
20. There are dead ends in the pipes of the purified water system, which easily breed microorganisms and bacteria.
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