SOP Title: Sampling and Analysis of Water for Chemical Analysis
- Objective:
To lay down the Procedure for Sampling and Analysis of Water for Chemical Analysis.
- Scope:
This procedure is applicable for Sampling and Analysis of Water for Chemical Analysis.
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- Responsibility:
- Quality Control: To prepare and review the SOP. To follow the Procedure for Sampling and Analysis of Water for Chemical Analysis as per this SOP.
- Quality Assurance Department: To review and approve the SOP and Annexure.
- Accountability:
Head Quality Control Department, Head Quality Assurance Department
- Procedure:
| 5.1 | Safety Precautions/Instructions: | |
| 5.1.1 | Before carry out sampling operation analyst should wear personal protective equipments such as protective hand gloves, nose masks and goggles. | |
| 5.2 | Procedure for Sampling of Water: | |
| 5.2.1 | 1. For water sampling, carry the transparent screw cap bottle. | |
| 5.2.2 | If sampling points located in core area; analyst should ensure itself that over gowning procedure should followed as per requirement of the particular area. | |
| 5.2.3 | 2. Prior to taking samples from the user points, drain OFF about 2 – 5 litres of water. | |
| 5.2.4 | Collect the water sample as follows:
Purified Water- about 800 ml Treated Water- about 200 ml Raw Water –about 500 ml 3. Soft Water – about 200 ml Potable Water – about 500 ml |
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| 5.2.5 | 4. Collect the sample and secure the lid tightly leaving a minimum headspace in the bottle. | |
| 5.2.6 | 5. Affix label or mark with marker pen on the sample bottle with sampling point number and date of sampling. | |
| 5.2.7 | 6. Bring all the samples to QC Department; make entry in “Water Inward Register” and assign the A. R. No. | |
| 5.3 | Assigning the A. R. No: | |
| 5.3.1 | Assigning of A.R Numbering system is as follows.
1. CD/XX/001 CD: Stand for code number of sample. XX: Stand for last two digits of current year 001: Stand for serial number |
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| 5.3.2 | For Ex. : PW/24/001
PW : Code number stand for Purified water 24 : Stands for last two digit of year 2024 001 : First serial number of the series. |
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| 5.3.3 | Water sample codes
PW : Code number stands for Purified water RW : Code number stands for Raw water TW : Code number stands for Treated water SW : Code number stands for Soft water PO : Code number stands for Potable water |
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| 5.3.4 | Define sampling points and their respective location. | |
| 5.3.5 | For daily water analysis, define water sampling plan. | |
| 5.4 | Analysis of Water: | |
| 5.4.1 | Carry out analysis within 2 hrs of sampling. If not then refrigerate the samples at 2 to 8 °C up to 8 hrs. | |
| 5.4.2 | Perform the analysis as per respective Pharmacopoeia IP/BP/USP or In-House Specification and record the data in their respective AWR. | |
| 5.4.3 | Get “Analytical Work Report” from QA. | |
| 5.4.4 | Analyst should refer Standard Testing Procedure to ensure that all required reagents, chemicals, accessories, equipment or instruments are standardised or validated and available in the laboratory. | |
| 5.4.5 | Analyst should fill in the necessary details on the Analytical Work Report according to ‘Water Inward Register’ and start the analysis as per Standard Testing Procedure and Specification. | |
| 5.4.6 | Analyst should refer to the SOP of instrument before operation and update the instrument operation logs immediately after use. | |
| 5.4.7 | After the analysis, analyst should hand over the Analytical Work Report to Supervisor/Reviewer for data checking. | |
| 5.4.8 | If Supervisor/Reviewer observed any discrepancy with analysis or analytical data, he / she should consult to Head of the Department for investigation. | |
| 5.4.9 | Supervisor shall initiate investigation as per SOP “Out of Specification” by filling OOS form. | |
| 5.4.10 | If due to holiday or any other reason, it is not possible to analyse the sample on the scheduled day of the week, perform sampling and analysis of those points on next working day. | |
| 5.5 | Seasonal Validation of Water System Plan: | |
| 5.5.1 | Sampling points coming under Potable Water are SP3, SP4, SP5, SP6 (in RO unit) and Purified water are SP7, UP1, UP2, UP3 and UP4 (in Production area) and UP5 (Quality Control) are allotted one A. R. No. | |
| 5.5.2 | During Seasonal Validation SP1 and SP2 are considered as Treated Raw Water points. | |
| 5.5.3 | Seasonal Validation should be carried out in three seasons’ Winter (December to January), Summer (April to May) and Monsoon (July to August). | |
| 5.5.4 | Samples should be drawn daily on fifteen consecutive working days for all points specified in Annexure of ‘Validation Sampling Plan’. | |
| 5.5.5 | Carry out the analysis as per the Pharmacopoeia or In House Specification and maintain the records. | |
| 5.5.6 | Prepare Seasonal Validation trend after completion in analysis as per define Annexure. | |
- Definition / Abbreviations:
6.1 Definition:
6.2 Abbreviations:
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| QC | Quality Control |
| QA | Quality Assurance |
| SP | Sampling point |
| UP | Users Point |
| No | Number |
| ml | millilitre |
| A.R. Number | Analytical reference Number |
| AWR | Analytical Work Report |
*Note – Ready to use SOP available in “DOWNLOAD” Section.