Company Name:: Version No.

Humanwell Pharmaceutical Ethiopia PLC 1

Title:
Document No:
SOP/SL/001
Chemical and Physical Monitoring of DI, WFI, and Page No.
Page 1 of 5
RO Waters

Effective Date Revision Date

Chemical and Physical Monitoring of DI, WFI, and RO

Waters

Prepared by： X X
Department Name Date

Approved by： Y Y
Department Name Date

Authorized by： Z Z
Department Name Date
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
SOP/SL/001
Chemical and Physical Monitoring of DI, WFI, and Page No.
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RO Waters

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1. Purpose

This procedure defines the requirements for the monitoring of chemical and physical testing
of water and the interpretation of the results related to the water system used in the injectable
manufacturing plant

2. Scope

This procedure is applicable to the water system used in the injectable manufacturing plant in
Humanwell Pharmaceutical Ethiopia PLC

3. Validity

This SOP is valid only until next revision date and if it bears control seal.

4. Responsibility

It will be the responsibility of the chemical lab analyst to follow the procedure. Quality
assurance manager is responsible for SOP compliance.

5. Material and Equipment

PH meter, Conductivity Meter, TOC analyzer and

6. Procedure
6.1. Use suitable sample containers (500 ml) that have been scrupulously cleaned of organic
residue.
6.2. Flush water for 1 minute prior to collecting samples.
6.3. Remove container stopper just before sample collecting.
6.4. Rinse the container twice using sampling water.
6.5. Collect the water sample with minimal headspace.
6.6. Immediately stopper the container after sampling.
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
SOP/SL/001
Chemical and Physical Monitoring of DI, WFI, and Page No.
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RO Waters

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6.7. Label sample with information showing sample location, date, and time, then sign for
“sampled by.”

Notes:

 In case of noncompliance, copy of reports should be sent to QA manager.

 Use extreme caution when obtaining samples for TOC analysis.
 Water samples can be easily contaminated during the process of sampling and
transportation to the testing facility.
 Collect the test solution in a tight container with minimal headspace, and test in a
timely manner to minimize the impact of organic contamination from the closure and
container.

Table1. Sampling Locations and Frequencies

Sample locations and number of samples shall be decided based on the system in place.

Sampling Points Activity Frequency

Provide location DIW tank Once weekly

Provide location WFI tank Once weekly

Provide location WFI tank Once weekly

Provide room no. WFI and DIW washing Once weekly

Provide room no. WFI and DIW solution Every working

preparation day

Provide room no. WFI and DIW (equipment Every working

 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
SOP/SL/001
Chemical and Physical Monitoring of DI, WFI, and Page No.
Page 4 of 5
RO Waters

Effective Date Revision Date

washing) day

Provide room no. DIW (steam sterilizer) As required

Note: It is appropriate to increase or decrease samples based on the trend

performance; the time and date should be determined according to the
activity.

6.8. RECORDS
 All water samples should be tested per current USP (pH, conductivity, and TOC). See
attachment (A).
 If TOC is not available, the samples are tested for pH, ammonia, calcium, carbon
dioxide, chloride, sulphate, and oxidizable substances. See attachment (B).
 For chilled water and water for injection, see attachment (C).

7. Abbreviations
 SOP - Standard Operating Procedure
 USP; united states pharmacopeia
 QC Quality control
 TOC Total organic content

8. Related Documents /Applicable document/

Related Title
Documents./
Quality Control Department Water
SOP/SL /001 /F01
Analytical Report Form
 Company Name:: Version No.
Humanwell Pharmaceutical Ethiopia PLC 1
Title:
Document No:
SOP/SL/001
Chemical and Physical Monitoring of DI, WFI, and Page No.
Page 5 of 5
RO Waters

Effective Date Revision Date

9. Revision History

Version
Revision Description
No.

1 New