WATER SAMPLING & ANALYSIS FOR VALIDATION

1.0. PURPOSE :
To validate the water System by providing a procedure for Sampling & analysis of water.
2.0. SCOPE :
Applicable for DM water (Purified Water) and Raw Water.
3.0. RESPONSIBILITY :
Quality Control Chemist / officer.
4.0. PROCEDURE :
4.1 MICROBIAL ANALYSIS:
4.1.1 Microbial Analysis of water is carried out as per table 4.12
4.1.2
Frequency, Method and Limit of Microbial Analysis

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4.1.3 Collect about 200ml of sample at the point of supply in a pre sterilised clean glass bottle & proceed for microbial analysis within 30 minutes of sampling.
4.1.4 Incase the sample is found above the alert limit for microbial count the cleaning and sanitation of DM plant, overhead tank as the case may be is carried out. After sanitation the equipment is repeatedly flushed with hot water and revalidated.
4.2 CHEMICAL ANALYSIS:
4.2.1 The chemical Analysis of water is carried out as per the table 4.2.2
4.2.2 Frequency, Method and chemical analysis of water.

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4.2.3 Collect the sample at the point of supply in a clean dry stoppered glass/plastic bottle.
4.2.4 Carry out the analysis as per the individual specification of DM water and Raw Water.
4.2.5 Analytical report is prepared which is authorized by QC Manger and report is filed in the respective file.
4.2.6 Incase of any deviation from the prescribed standards, it is immediately informed to Quality Assurance and corrective action is taken and same to be documented.
4.2.7 The result for all the points of sampling is summarized in the format for validation of Raw DM water, which is reviewed by QC manager along the QA.
4.2.3 Collect the sample at the point of supply in a clean dry stoppered glass/plastic bottle.
4.2.4 Carry out the analysis as per the individual specification of DM water and Raw Water.
4.2.5 Analytical report is prepared which is authorized by QC Manger and report is filed in the respective file.
4.2.6 Incase of any deviation from the prescribed standards, it is immediately informed to Quality Assurance and corrective action is taken and same to be documented.
4.2.7 The result for all the points of sampling is summarized in the format for validation of Raw DM water, which is reviewed by QC manager along the QA.

1.0 PURPOSE : To provide a procedure for visual inspections of control samples
2.0 SCOPE : To inspect the control sample by visual means.
3.0 RESPONSIBILITY : QC Chemist and QC Manager.
4.0 PROCEDURE
4.1 : All the control samples, of tablets, powder and liquid products
kept in control sample room shall be checked visually.
4.2 : The sample shall be checked once in 6 months.
4.3 : The sample shall be checked for the following parameters
i) Appearance of the tablets, powder and liquid.
ii) Colour change in any
iii) Solidification or sedimentation in case of liquids.
4.4 : The observations are to be recorded in visual inspection report.
4.5 : Incase of discrepancies the report should be forwarded to QA and production to take further action.

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