WATER SYSTEM QUALIFICATION IN PHARMA

1. URS for Purified Water System
2. IQ for Process Water
3. IQ for Purified Water Generation System
4. IQ for Purified Water Distribution System
5. OQ for Purified Water Generation System
6. OQ for Process Water Generation & Distribution System
7. OQ Protocol Cum Report for Purified Water Pre-treatment System
8. OQ Protocol Cum Report for Purified Water Generation System
9. Operational Qualification Protocol for Purified Water Storage & Distribution System
10. OQ Protocol Cum Report for Purified Water Distribution System
11. PQ for Process Water
12. PQ for Purified Water Generation System
13. PQ for Purified Water Storage & Distribution System
14. Qualification of TOC Analyser
15. Installation Qualification for Purified Water Generation System
16. Operational Qualification Protocol for Purified Water Generation System
17. Installation Qualification Protocol for Purified Water Storage & Distribution System
18. Operational Qualification Protocol for Purified Water Storage & Distribution System
19. Operational Qualification for PLC System of Soft Water Distribution System
20. Performance Qualification for Generation & Distribution System (Phase – I)
21. Performance Qualification for Generation & Distribution System (Phase – II)
22. Performance Qualification for Generation & Distribution System (Phase – III)
23. Requalification Protocol for Purified Water Storage & Distribution System
24. Hydro Test Qualification Protocol for Purified Water Tank
25. Qualification for Spray Ball Coverage Test in WFI System
26. Drain Time Validation Protocol
27. Drain Time Validation Report
28. CONTROL PHILOSOPHY FOR PRETREATMENT SYSTEM
29. CONTROL PHILOSOPHY FOR GENERATION AND DISTRIBUTION SYSTEM
30. CONTROL PHILOSOPHY FOR WFI DISTRIBUTION SYSTEM
31. INSTALLATION QUALIFICATION, OPERATIONAL QUALIFICATION AND PERFORMANCE QUALIFICATION (IQ, OQ & PQ) PROTOCOL OF EDI

STANDARD OPERATING PROCEDURES OF WATER SYSTEM

1. SOP for Qualification of Water System
2. SOP for Specifications of Mixed Bed Unit
3. SOP for Sanitization of Mixed Bed Unit
4. SOP for Sanitization of Multi Column Distillation Plant
5. SOP for Sanitization of Purified and Distilled Water Loop
6. SOP for Sanitization of RO Water Plant
7. SOP for Specifications of Filters for Purified Water and WFI
8. SOP for Specifications of UV Lamps
9. SOP for Calibration of pH Meter
10. SOP for Chemical Preparation in Utility Safety Measures
11. SOP for Chlorination Dosing in Raw Water
12. SOP for Cleaning of Mixed Bed Unit Resins
13. SOP for Cleaning of Reverse Osmosis (RO) Plant Membrane
14. SOP for De-Scaling of Multi Column Distillation Plant
15. SOP for Operation of Mixed Bed
16. SOP for Operation of Multi Column Distillation Plant
17. SOP for Operation of Multi Grade Sand Filter (MGF)
18. SOP for Operation of Reverse Osmosis Plant
19. SOP for Spray Ball Coverage Verification
20. SOP for Passivation of Pure Steam Generation and Distribution System
21. SOP for Operation of PLC based Water System
22. SOP for Passivation of Equipment & Water System
23. SOP for UV Intensity measurement and Calculation of Dose
24. SOP for Testing of Water Hardness
25. SOP for Spray Ball Coverage Verification
26. SOP for Sanitization of UF Membrane
27. SOP for Sanitization of RO Membrane
28. SOP for Sanitization of EDI System
29. SOP for RO Membrane loading & replacements
30. SOP for Replacement of Sand in Multi Grade Filter
31. SOP for Replacement of Resins of Mixed Bed Unit
32. SOP for replacement of Resin at Softener
33. SOP for Replacement of Cartridge Filter and Vent Filter
34. SOP for Regeneration of Softener
35. SOP for Regeneration of Mixed Bed Unit
36. SOP for Operation of Purified Water Circulation Loop
37. SOP for Operation of MCDP
38. SOP for Operation of Pretreatment Plant
39. SOP for Sanitization of WFI Storage and Distribution System
40. SOP for Replacement of Media in Multi Grade Filter
41. SOP for FDV Challenge Test
42. SOP for Circulation Loop Qualification for Purified Water System
43. SOP for Sanitization of Purified Water Storage and Distribution System
44. SOP for Passivation of Purified Water Storage and Distribution System
45. SOP for Procedure for Operation and Replacement of Ultra Violet Lamps
46. SOP for Filter Integrity Testing and Replacement of Vent filters
47. SOP for Sanitization of Purified Water Generation System
48. SOP for Solution Preparation and Dosing in Purified Water Generation System
49. SOP for Water Sampling for Chemical Analysis and Trend Preparation
50. SOP for Microbiological analysis of Raw water, Process Potable water & Purified water
51. SOP for Microbiological Analysis of Water for Injection and Pure Steam
52. SOP for Sampling of Raw Water, Potable water, Purified Water and Pure Steam for Microbiological Analysis
53. SOP for Cleaning and Sanitization of High Density Polyethylene Soft Water Storage Tank
54. SOP for Operation of Purified Water Circulation Loop
55. SOP for Operation of MCDP
56. SOP for Cleaning & Sanitization of Purified Water System
57. SOP for Sampling procedure of Purified Water and Raw Water
58. SOP for Handling of Wash Water
59. SOP for Sanitization of RO EDI System
60. SOP for Sterilization of WFI Water Tank Loop Line
61. SOP for Passivation of Equipment & Water System
62. SOP for Handling of Out of Limit Results in Environmental Monitoring and Water Analysis
63. SOP for Operation and Maintenance of Water Purification System
64. SOP for Procedure for Analysis of Water
65. SOP for Sampling and Testing of Potable Water
66. SOP for Sampling and Testing of Purified Water
67. SOP for Sampling and Testing of Source Water
68. SOP for Water Sampling Procedure
69. SOP for Recording of Water Consumption Data
70. SOP for Analytical Data of Water Analysis
71. SOP for Sampling procedure for water samples
72. SOP for Analysis of Water and Pure Steam samples
73. SOP for Analysis of Water
74. SOP for Identification & Characterization of Environmental and Water isolates
75. SOP for Microbial Limit Test of Water, Non-sterile Product & Material
76. SOP for Procedure for the detection of Bacterial Endotoxin in water for Injection and Pure Steam Condensate by Gel Clot method
77. SOP for Chlorination Dosing in Raw Water
78. SOP for Operation of Ultra Pure Water System
79. SOP for Preventive Maintenance of Distilled Water Plant (WFI-Plant)
80. SOP for Procedure for De-Chlorination in Potable Water
81. SOP for Procedure for Operation of Raw Water Pumps
82. SOP for Procedure for Wash Water Sample Analysis
83. SOP for Sanitization of Purified and Distilled Water Loop
84. SOP for Sanitization of RO Water Plant
85. SOP for Testing of Water Hardness
86. SOP for Recording of Water Consumption Data
87. SOP for Operation of Purified Water System
88. SOP for Procedure for Integrity Testing & Replacement of Vent Filter of Water System

Water System Qualification in pharma is a core GMP activity that proves the Purified Water (PW) or Water for Injection (WFI) system consistently produces water that meets its intended quality for manufacturing, cleaning, and laboratory use. A qualified system reduces microbiological risk, prevents endotoxin and chemical contamination, and supports reliable batch release. Regulators expect a lifecycle approach aligned with GMP, USP/EP specifications, and robust microbiological control of the loop.

1) User Requirements and Design

Qualification starts with a User Requirements Specification (URS) that defines capacity, quality grade (PW or WFI), distribution loop temperature, sanitization strategy, materials of construction, and monitoring limits. Engineering delivers a compliant design using P&IDs, proper slopes, controlled dead-legs, drainability, and verified weld quality, supported by risk assessments.

2) Installation Qualification (IQ)

IQ documents that the system is installed as designed. It verifies equipment lists, piping and instrument identification, calibration status, material certificates, weld logs/boroscope records, filter ratings, tank vent filters, heat exchangers, and utility connections. IQ also confirms SOP availability, operator training, and preventive maintenance plans.

3) Operational Qualification (OQ)

OQ demonstrates that controls, alarms, and operating ranges work correctly. It challenges flow, pressure, temperature, sanitization cycles (hot water, steam, or chemical), RO/EDI performance, UV units, and interlocks. OQ confirms online monitoring (conductivity, TOC, temperature) and data integrity for trending.

4) Performance Qualification (PQ)

PQ proves consistent performance under routine conditions. A defined sampling plan covers the generation unit and multiple points of use in the loop. Testing typically includes conductivity, TOC, microbial counts, and endotoxin (for WFI), plus periodic chemical and bioburden identification. Results establish alert/action limits and demonstrate robustness.

5) Continued Verification

Routine monitoring, sanitization, deviation management, and change control maintain the qualified state. Requalification follows major changes, repeated excursions, or extended shutdowns.