1.0 OBJECTIVE:To lay down the procedure for sampling and testing of Potable and purified water for Microbiological and chemical analysis.
2.0 SCOPE:This SOP shall be applicable to Microbiological and Chemical Section of Quality Control.
3.0 RESPONSIBILITY:Quality Control Chemist and Microbiologist.
4.0 ACCOUNTABILITY:Sr. Manager Quality Assurance.
5.1 Chemical Analysis:5.1.1 Take a clean, dry conical flask (500 ml capacity) and plug it with cotton.
5.1.2 Take the flask to the sampling area.
5.1.3 Open the tap/valve of the sampling point and let the water flow for about 30 seconds.
5.1.4 Unplug the flask and rinse it with the running water.
5.1.5 Collect about 500 ml of the water sample in the flask.
5.1.6 Plug the flask immediately and label it, mentioning the sampling point and date.
Related: Sampling, Preservation and Storage Procedure of Water Sample
5.2 Microbiological Analysis:5.2.1 Take a clean, dry conical flask of 250 ml capacity and sterilize by autoclaving at 15 lbs pressure (121° C) for 15 minutes.
5.2.2 Take the sterile, plugged flask to the sampling area.
5.2.3 Open the tap/valve of the sampling point and let the water flow for about 30 seconds.
5.2.4 Unplug the flask and collect about 250 ml of the water sample in the flask.
5.2.5 Plug the flask immediately and label it, mentioning the sampling point and date.
5.2.6 Carry out microbiological analysis of the sample as per the specifications.
5.3 Purified Water:5.3.1 Purified water shall be sampled from the following sampling points every day for chemical analysis and once in a week (first working day of the week) for microbial analysis.
i. D.M Water Storage Tank
ii. Manufacturing Area
iii. Washing Area
iv. Filling & Sealing Area
vi. Coating Room
5.3.2 The sampling points of purified water in the production area are marked with a Yellow colour for the ease of identification.
5.3.3 Purified water shall be analysed as per the available specifications.
5.3.4 The results shall be recorded in format. A copy of the report shall be sent to the respective departments.
5.3.5 The limit of total microbial count of purified water shall be 100 cfu/ml. The alert limit shall be 50 cfu/ml and the action limit shall be 75 cfu/ml.
5.3.6 In case the microbial count of a purified water sample exceeds the alert limit, the maintenance department and the respective department shall be informed immediately, in writing.
5.4 Raw Water:5.4.1 Raw water shall be sampled once a month from the raw water storage tank/raw water sampling point for chemical and microbiological analysis.
5.4.2 Raw water from any one of the following sampling points shall be collected every month on rotational basis.
i. Manufacturing Area
ii. Washing Area
iii. Filling & Sealing Area
v. Coating Room
5.4.3 The sampling points of raw water in the production area are marked with a green spot for ease of identification.
5.4.4 Raw water shall be analysed as per the specifications available.
5.4.5 The results shall be recorded in format.
6.0 ABBREVIATIONS:6.1 SOP : Standard Operating Procedure
6.2 QA : Quality Assurance
6.3 QC : Quality Control
6.4 Dept. : Department
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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