Water Sampling, Purpose :
Water Sampling, The purpose of this SOP is to describe the procedure for sampling and analysis of water in quality control laboratory.
Water Sampling, Scope :
This procedure is applicable for sampling and analysis in Quality Control Laboratory for purified water, water for injection, purified steam condensate, potable water, drinking water and effluent treatment plant water from different user points used in XX Pharmaceuticals Ltd.
Definitions / Abbreviation:
[][]QC: Quality Control
[][]QA: Quality Assurance
[][]QCom: Quality Compliance
[][]COA: Certificate of Analysis
[][]WFI : Water for Injection
[][]PW: Purified water
[][]ETP: Effluent treatment plant
Responsibilities:
The roles and responsibility is as follows:
Lab Attendant, QC
[][]To collect water sample from different sampling points.
Officer / Executive, QC Officer / Executive, QC
[][]To prepare schedule sampling of water.
[][]To organize the sampling of water.
[][]Analysis of water and preparation of respective test report.
[][]Trend analysis of water.
[][]To ensure that this procedure is followed.
[][]To maintain the records properly as per SOP.
Sr. Executive, QC
[][]Reviewing of test report.
Manager, Quality Control
[][]Approval of test report.
[][]To ensure implementation of the SOP after training.
Head of Quality Assurance
[][]To ensure the overall implementation of the SOP.
[][]Approval of the SOP.
Procedure:
Precaution(s):
[][]Use gloves, mask & cap during sampling.
[][]Collect sample carefully to avoid contamination.
[][]Carefully collect water sample with high temperature and close the cap of container freely.
Sample Collection :
[][]Take required number of 500 ml to 1 Liter clean glass containers with cap for sampling.
[][]Open sampling points such as tap fixtures / hosepipe and allow water to run for not less than 1 minute.
[][]Rinse the container with respective water.
[][]Collect approximately 500 ml of water and immediately recap the sample containers after collecting samples. Keep the cap slightly loose when water temperature is above 30°C.
[][]Label the sample container providing information such as name of water, sample point no. / location, time, initial of sampler and date of sampling.
[][]Transfer the sample immediately to laboratory and analyze the sample within 24 hours of sampling. Preserve the sample in refrigerator (2°C to 8°C), if required.
[][]Entry information of sampling in sampling register after sampling.
Test Schedule :
Perform the test as per the following schedule :
Source of Water /Test frequency
Potable Water/ Once in a month
Purified Water/ Once in 14 days
ETP Water /Once in a week
Water for Injection/ Once in a week
Chemical Analysis :
[][]Perform analysis of water as per respective specification and method.
[][]Compile the raw data and prepare the certificate of analysis as per respective annexure with the test results & take approval of the COA.
[][]Share the water test reports with Engineering department and or Production department.
[][]Water test results are to be evaluated on a continuous basis and should be summarized in trend analysis report six monthly in order to identify significant trends.
[][]Inform respective department i.e. Engineering, Production and Quality Assurance Department whenever atypical data found beyond alert limit.
[][]Inform respective department i.e. Engineering, Production and Quality Assurance Department for taking actions whenever data found beyond action limit.
Annexure:
Annexure-I : Format for Certificate of Analysis for Potable water/Drinking water
Annexure-II : Format for Certificate of Analysis for Purified water/Water for injection/Purified Steam Condensate
Annexure-III : Format for Certificate of Analysis for Effluent Water
Annexure-IV : Format for Water Sampling Register
Annexure-V : Water sampling points