Wednesday, December 1, 2010

Monitor The Quality Of Purified Water

1.0   Purpose           :   To provide instructions for monitor the quality of purified water.

2.0   Objective        :   To provide a documented procedure for monitor the quality of purified water.

 3.0   Scope               :  This procedure for monitor the quality of purified water in QC Department of
                              ----Pharmaceutical. Ltd, 
4.0    Responsibility :
·      Primary     : QC Chemist
·      Secondary : Overall: QC Officer

5.0    Procedure  :

·      Preparation of sample containers
Ø      For Chemical analysis:  Clean 500ml glass containers.  Rinse with purified water.
Ø      Close the containers and wrap the neck securely with aluminum foils.  Sterilize at 121 0C for 20 minutes.
·      Collection of water for Chemical analysis.
Ø      Collect one sample each for Chemical analysis daily.
Ø      Before collection of sample, open the valve and allow the water to drain for 1 min.
Ø      For Chemical analysis sample, rinse the container with purified water from the sampling point and collect approximately 500ml of water.
Ø      Close the containers, meanwhile continuing to allow the water to run through the valve.
Ø      Collect the sample in the container without rinsing and immediately close it with the

stopper.  Do not fill the bottle up to the neck.
Ø      Wrap the neck with Aluminum foil to avoid any contamination during transit..
Ø      Close the valve and bring both the samples to IPQA Laboratory.
Ø      Wipe the container dry from outside and label them with the following details,
o        Name of the sample
o        Date of collection
o        Sampler’s Name
Ø      Send  the samples to QC Lab for analysis
Ø      Perform the analysis of purified water samples
o        Chemical analysis as per specification
Ø      Perform the analysis of water samples on the same day of sampling.
Ø      On completion of analysis, send a copy of Certificate of Analysis to Manufacturing dept.    
In case the sample fails in Chemical testing follow the procedure after inform to QC in charge and QA Dept.

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