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20 common GMP certification questions for pharmaceutical water equipment systems
- 2019-09-02-

After the new version of the GMP certification was issued, many pharmaceutical companies will encounter some problems in the GMP certification of water equipment systems. The following is a collection of 20 common GMP certification issues for pharmaceutical water equipment manufacturers.

1. The water equipment is not equipped with a PID chart.

2. The sampling point number is not affixed to the pure water equipment.

3. The water system needs to be added with a water point number; the pipeline on the water storage tank has no flow direction identification.

4. In the physical and chemical test records of water: there is no original print record for non-volatile matter measurement and weighing; the conductivity test should be added to the unit; the entire record is too thick and the operability is not strong.

5. The water system comes out of the EDI to use water, but the pipelines and valves, water pumps, and pressure gauges on site are not installed in accordance with the standards for water use, and there is a risk of pollution.

6. The verification of the water system did not verify the accuracy of the automatic solenoid valve.

7. There is no drawing for online conductivity monitoring of installation water.

8. No management design drawing for water use, non-sanitary connection of pipelines, no daily monitoring, pipeline design is not conducive to sampling.

9. Water irrigation and welding do not meet the requirements, and one side welding and two sides forming processes should be used, and an endoscope photo of the water pipeline should be provided.

10. There is no sampling record for the water equipment system; a flow meter should be installed at the water return water.

11. The water system needs to conduct a weekly full inspection of the total delivery, total return, storage tanks and remote water points, and the remaining water points are inspected monthly.

12. Verification of water system, verify the performance of IQCQDQ of water equipment system.

13. The design, installation, ozone disinfection basis, welding, verification and other parts of water do not meet the requirements.

14. The drawings of the water equipment are not consistent 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 water pipe interface should be sanitary clamp connection method, and the use of wire connection method should be avoided.

18. The water section pipeline should use 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 water system pipes, which easily breed microorganisms and bacteria.

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