SOP for Statistical Study for Trend Analysis of Purified Water and Water for Injection

1.0 OBJECTIVE

To evaluate the uniform quality of D.M. water and W.F.I by the trend of the results.

2.0 SCOPE

This procedure gives guidelines for evaluating the results and to take corrective action if the results exceed the action level.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant/Executive
3.2 Checking: Executive /Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 Purified Water: For each critical sampling point, prepare a trend report once in a week for following critical parameters.
1. Microbial count
2. Chemical analysis: pH, Conductivity, Total organic carbon.
5.2 W.F.I: For each critical sampling point in parenteral area prepare a trend report once in a week for following critical parameters.
1. Microbial count
2. Chemical analysis: pH, Conductivity, Total organic carbon.
5.3 Plot the statistical control graph for all above critical parameters. Indicate alert and action level in the graph.
5.4 The water system is considered as satisfactory for its quality of output, If results are within the acceptance.
5.5 Conclude the trend analysis from the graphical values for consistent quality of purified water and W.F.I. Keep track of results and indicate high lighted in case reaches to Alert or Action level.
5.6 Sign the trend report, get checked by Q.C. Incharge and approved by Q.A.
Related: Water for Injection System Validation Protocol

6.0 ABBREVIATIONS

6.1 SOP = Standard Operating Procedure
6.2 Q.A. = Quality Assurance
6.3 Q.C. = Quality Control
6.4 W.F.I = Water for injection

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