STANDARD OPERATING PROCEDURE SAMPLING AND TESTING OF D.M. WATER

STANDARD OPERATING PROCEDURE

SUBJECT :                     SAMPLING AND TESTING OF D.M. WATER

DEPARTMENT         : QA SOP NO.                      : Page No                       : Effective Date             : Next Review                : Version No                  :

1.0       OBJECTIVE:

To provide guidelines for sampling and testing of D.M. water.

2.0       SCOPE:  

To lay down a procedure for sampling and testing of D.M Water.

3.0       PROCEDURE:

3.1       Water from sampling point is drained for 5 minutes before drawing the sample for physical and chemical analysis.

           

3.2       Sample for microbiological analysis is drawn aseptically in sterile container.

3.3       Microbiological analysis is done within 4 hours of the drawing the samples.

3.4       Sample for microbiological analysis is drawn before the samples for physical and chemical analysis.

           

3.5       For Microbiological analysis the samples are to be drawn from various sampling points.

           

3.6       D.M water must meet I.P. specifications and is reported as per the format of Raw Material Analytical Report, Annexure-1 Sop No.

3.7       If the results are found out of specification then inform GM QA and check the following

3.7.1    Source of input water.

3.7.2    Check the solutions and reagents used for testing.

3.7.3     Check the calibration status of the equipment used for testing and if required cross check or recalibrate.

3.7.4    Then recheck the sample collected.

PREPARED BY                            REVIEWED BY                                       APPROVED BY

SOP No.       :

Page             :

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3.7.5    If the water does not meet the required standards then resample and reanalyze.

3.8       As the micro testing will take 5 days to complete the analysis approval will be given on the basis of chemical analysis.

3.9  DM water is tested for the following parameters,

Appearance, Aciditity or Alkality, Calcium and magnesium, Heavy metals, Chloride, Sulphate, Oxidisable substances, Residue on evaporation and free chlorine content with the help of chlorine test kit.                   

 If these parameters are within the limits then the DM water can be approved for use but the other tests as per specification will be done and report prepared after completion of testing.

4.0       FREQUENCY: 

4.1       Physical and chemical analysis is done daily.

4.2       Microbiological analysis is done in departments whenever production activity is planned.

4.3       Microbiological analysis is done on daily basis, where production is planned.

5.0       RESPONSIBILITY: Executive (Q.C).

6.0       REVIEW GUIDE: DM Water analytical reports file.

7.0       ANNEXURE: 1. Raw material analytical report.

                                      2. Water sampling points

            

8.0       SOPs DISTRIBUTION:

            This SOP shall be distributed to following Departments:

Name of the Department	Master Copy	Circulatory Copy
QA/QC	√	√
Production	x	x
Warehouse	x	x
General	x	x
Maintenance	x	x

                                                                                             

PREPARED BY                            REVIEWED BY                                       APPROVED BY