How to quickly pass GMP certification for purified water equipment
Guide: Purified water equipment is used to meet the needs of various industries to prepare purified water. It is mostly used in medicine, biochemical, chemical, hospital and other industries. The whole system is made of SUS304L or SUS316L all stainless steel materials, and before the water point All must be equipped with ultraviolet and ozone sterilization devices. The core technology of purified water equipment adopts the latest technology such as reverse osmosis and EDI, and has designed a set of high-purity water treatment process in a targeted manner to meet the water requirements for the preparation of purified water and large infusion in pharmaceutical factories and hospitals.
The design and manufacture of the purified water equipment system must meet the GMP certification requirements in addition to the water quality of the 2010 edition of the Pharmacopoeia or other Pharmacopoeia standards. Purified water equipment for biomedical pharmaceuticals pays more attention to these two points. What are the requirements for GMP for purified water equipment systems? How should we avoid these problems? How to quickly pass GMP certification?
Based on the relevant requirements of GMP certification and the experience of many GMP purified water equipment cases, Xiaobian summarizes some common GMP certification issues for reference:
1. The purified water is not installed with the PID diagram. 2. The pure water station does not have the sampling point number. 3. The water point number is required for the purified water; the pipeline on the first floor of the purified water storage tank has no flow direction mark;
4. Purification water physical and chemical detection record: no volatile matter detection weighing no original print record; conductivity detection should be added to the unit;
5. The purified water system is purified water from the EDI, but the pipelines and valves, water pumps, and pressure gauges on the site are not cleaned by the standard of purified water, which poses a risk of contamination.
6. The verification of the purified water does not verify that the action of the automatic solenoid valve is correct.
7. There is no drawing when installing purified water online conductivity monitoring.
8. There is no management design drawing of purified water, the pipeline is not sanitary connection, there is no daily monitoring, and the pipeline design is not conducive to sampling. 9. Purified water irrigation and welding do not meet the requirements,
10. There is no sampling record of purified water; the flow meter should be installed in the return water of purified water. 11. The purified water system needs to carry out weekly full inspection of the total delivery, total return, storage tank and the farthest water point. The remaining water points are fully inspected every month. Verification of the purified water system 13. The design, installation, ozone disinfection basis, welding, verification and other parts of the purified water do not meet the requirements. 14. The purified water drawings do not conform to the actual conditions, and each control valve should be indicated on the drawings;
15. Pipes, water storage tanks, electric welding problems 16. Reserve water outlets, there should be a thermometer at the water return to control the temperature change, there should be a flow monitoring meter
The design and manufacture of the purified water equipment system must meet the GMP certification requirements in addition to the water quality of the 2010 edition of the Pharmacopoeia or other Pharmacopoeia standards. Purified water equipment for biomedical pharmaceuticals pays more attention to these two points. What are the requirements for GMP for purified water equipment systems? How should we avoid these problems? How to quickly pass GMP certification?
Based on the relevant requirements of GMP certification and the experience of many GMP purified water equipment cases, Xiaobian summarizes some common GMP certification issues for reference:
1. The purified water is not installed with the PID diagram. 2. The pure water station does not have the sampling point number. 3. The water point number is required for the purified water; the pipeline on the first floor of the purified water storage tank has no flow direction mark;
4. Purification water physical and chemical detection record: no volatile matter detection weighing no original print record; conductivity detection should be added to the unit;
5. The purified water system is purified water from the EDI, but the pipelines and valves, water pumps, and pressure gauges on the site are not cleaned by the standard of purified water, which poses a risk of contamination.
6. The verification of the purified water does not verify that the action of the automatic solenoid valve is correct.
7. There is no drawing when installing purified water online conductivity monitoring.
8. There is no management design drawing of purified water, the pipeline is not sanitary connection, there is no daily monitoring, and the pipeline design is not conducive to sampling. 9. Purified water irrigation and welding do not meet the requirements,
10. There is no sampling record of purified water; the flow meter should be installed in the return water of purified water. 11. The purified water system needs to carry out weekly full inspection of the total delivery, total return, storage tank and the farthest water point. The remaining water points are fully inspected every month. Verification of the purified water system 13. The design, installation, ozone disinfection basis, welding, verification and other parts of the purified water do not meet the requirements. 14. The purified water drawings do not conform to the actual conditions, and each control valve should be indicated on the drawings;
15. Pipes, water storage tanks, electric welding problems 16. Reserve water outlets, there should be a thermometer at the water return to control the temperature change, there should be a flow monitoring meter
YT-H706
YT-H706
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