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SOP for Sampling Plan for Purified Water and Potable Water

Potable water also known as drinking water, comes from surface and ground sources and is treated to levels that meet state and federal standards for consumption. Water from natural sources is treated for microorganisms, bacteria, toxic chemicals, viruses and fecal matter.

Purified water is water that's been mechanically filtered or processed to remove chemicals and impurities. The purification process removes contaminants including bacteria, chemicals, and toxins from tap water or ground water.


OBJECTIVE 
To lay down a procedure for sampling plan for purified water and potable water. 

SCOPE 
This procedure applies to the pharmaceutical manufacturing facilities of XYZ Limited.  

RESPONSIBILITY 
Execution : Chemist and above – QC department. 
Checking : Asst. Manager and above – QC department 

PROCEDURE 
Sampling Points: 
  • National water outlet. 
  • Outlet of purified water storage tank. 
  • Non Beta Granulation -1 
  • Non Beta Granulation -2 
  • Non Beta Granulation -3 
  • Liquid mfg-1 
  • Liquid mfg-2

Flow diagram: 

PW/005/G-1:Non Beta Granulation -1 
PW/006/G-2:Non Beta Granulation -2 
PW/007/G-3:Non Beta Granulation -3 
PW/003/L-1:Non Beta Liquid -1 
PW/004/L-2:Non Beta Liquid -2. 

Schedule for microbial testing of water samples: 
External Lab                     Total count (Frequency) 
Purified Water                 Once in six months 
Potable Water                 Once in six months 

Sample Quantity: 
Raw water : Microbial analysis – 1000ml 
Purified water – 500ml from each sampling point. 

Schedule for Chemical Testing of water sample: 
External Lab                                     Total count (Frequency) 
Purified Water                                 Once in six months 
Potable Water                                 Once in six months 

Inhouse Lab                                     Total count (Frequency) 
Purified water                                 Every day 
                                                           (To cover the entire user points) 

Sampling and testing of water sample: 
  • Sample quantity shall be taken as, Raw water: Chemical analysis – 1.0 Lit. & purified water – 1.0 Lit. from each sampling point. 
  • Collect the purified water in this bottle and make sure it is properly closed. 
  • Take the samples for analysis in the quality control department and carry out the complete analysis as per the testing procedure of purified water. 
  • Record the results in the analysis report and then approve the water for manufacturing use if it complies as per BP specifications. 
  • The analysis for microbial testing is to be done every six months as per schedule. 
  • Inform the government chemist or independent laboratory to come and sample the purified water and do complete analysis coupled with microbial testing as per BP specifications. 

ABBREVIATION(s) 
SOP : Standard Operating Procedure 
Q.A : Quality Assurance 
No. : Number 
Q.C : Quality control 
ml : Milliliter 
Lit. : Liter 

ANNEXURE
Annexure - 1 -- Sampling points and plan for the water system 

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REVISION HISTORY

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