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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