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REF: WHO 32	WATER FOR INJECTION	Yes	No	NA
1	Which treatment system is used to get Water for Injection?
2 Section 17.33	Are system schematics shown? Are distribution network layouts shown? Are sampling points shown?
3 Section 14.35	Are there written procedures for the operation of the system?
4 Section 17.33	What is the production capacity in liters/hour?
4.1	What is the average consumption?
5	If a reverse osmosis system is used:
5.1	Is a two-steps system or double osmosis system used on line?
5.2	Is the water that feeds the system pre-treated?
5.3	What is the pre-treatment system?
5.4	Is the system sanitized?
5.4.1	What is the sanitation frequency?
5.4.2	Are records kept?
5.5	In case that chemical sanitation is undertaken, are sanitizing agent residues investigated?
5.5.1	Are records kept?
6	If distillation is used:
6.1	Is the water that feeds the system pre-treated?
6.2	Which is the pre-treatment system? ____________________________________________
REF: WHO 32	WATER FOR INJECTION	Yes	No	NA
7	Is there a storage tank for the Water used for injection?
7.1	Is the tank made of sanitary material?
7.2	What is its capacity?
7.3	Does it have a hydrophobic vent absolute filter?
7.4	Are periodic integrity tests undertaken?
7.5	Are records kept?
8	Are pipes used in the distribution of Water for Injection up to the point of use?
8.1	Are pipes made of sanitary material?
8.2	Is there any type of heat exchanger in the system?
8.3	If “YES", are there guarantees that the heat exchanger is not a source of contamination?
9	Is there a SOP for the sanitation of the water storage and distribution system?
9.1	What is the sanitation method used?
9.2	What is the sanitation frequency?
9.3	Are records kept?
9.4	In case of chemical sanitation, is the existence of sanitizing agent residues investigated?
9.5	Are records kept?
9.6	If sanitation is thermal, is it undertaken periodically by a fluent steam circulation?
9.7	Are records kept?
REF: WHO 32	WATER FOR INJECTION	Yes	No	NA
10 Section 17.33	If water is not used the same day of its production, is the water maintained above 80 °C or below 4º and with constant recirculation through a loop up to points of use?
11	If recirculation is below 4oC, ¿are additional precautions taken to prevent access of microbial contaminants and its proliferation?
11.1	What are those precautions? ____________________________________________
11.2	Do the storage and recirculation of the water at this temperature ensure its quality according to its use?
12	If the water is produced by reverse osmosis, is there any system to maintain its quality?
13	If the company manufactures parenteral products, does it use water for injections as a raw material?
14	If the company manufactures parenteral products, does it use water for injections for the final rinse of equipments and components used in manufacturing?
15	Is a non-continuous and non-recirculated production system of Water for injection used?
15.1	If this is the case: is water used only during the day of its production?
15.2	Is water disposed at end of the day of its production?
15.3	Is each batch released by Quality control by physicochemical and bacterial endotoxins tests according to the procedures established by current editions of official pharmacopoeias or by alternative methods validated?
REF: WHO 32	WATER FOR INJECTION	Yes	No	NA
15.4	Are microbiological tests of each batch undertaken?
15.5	Is an action limit established?
15.6	Is action limit no more than 10 cfu /100mL ?
15.7	When the action limit is exceeded, is an investigation of the system always undertaken?
15.8	Is the investigation report shown?
15.9	Are measures undertaken?
15.10	What measures are undertaken?
16	Is there a continuous system of for the production of water for injections used?
16.1 Section 17.42	Is there a continuous monitoring of the water quality?
16.2	Is there an automatic system to prevent the use of the water for injections, if it is out of specifications?
16.3	If there is an automatic system to prevent the use of the water for injections, if it is out of specifications, is it checked to verify that it is operating properly?
16.4	Are physicochemical and bacterial endotoxin tests undertaken according to the procedures established by current editions of EP, USP, and latest edition of National Pharmacopoeia or by an alternate validated method?
16.5	Are microbiological tests undertaken daily or with an established frequency which is properly validated?
16.6	Is an action limit established?
16.7	Is the action limit no more than 10 cfu / 100mL?
REF: WHO 32	WATER FOR INJECTION	Yes	No	NA
16.8	When the action limit is exceeded, is an investigation of the system always undertaken?
16.9	Is the investigation report shown?
16.10	Were measures taken?
16.11	What measures were taken?
17	Are sampling sites rotated so that all points of use are covered?
18	Is there a SOP for sampling?
19	Is there a preventive maintenance program that includes the water for injection system?
19.1	Are records kept?

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