SOP for Statistical Analysis of Purified Water Trend

OBJECTIVE

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

SCOPE

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

RESPONSIBILITY

Doing: Technical Assistant/Executive

Checking: Executive /Manager

ACCOUNTABILITY

Head of the Department

PROCEDURE

Purified Water

• For each critical sampling point, prepare a weekly trend report for the following critical parameters.

1. Microbial count
2. Chemical analysis: pH, Conductivity, Total organic carbon.

W.F.I

• For each critical sampling point in the parenteral area prepare a trend report once in a week for the following critical parameters.

1. Microbial count
2. Chemical analysis: pH, Conductivity, Total organic carbon.

• Plot the statistical control graph for all the above critical parameters. Indicate alert and activity level in the graph.
• The water system is considered satisfactory for its output quality if the results are within acceptance.
• Conclude the trend analysis from the graphical values for consistent quality of purified water and W.F.I. Keep track of results and indicate highlighted in case reaches to Alert or Action level.
• Sign the trend report, get checked by Q.C. Incharge, and approved by Q.A.

ABBREVIATIONS

SOP: Standard Operating Procedure

Q.A: Quality Assurance

Q.C: Quality Control

W.F.I: Water for injection

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: SOP for Sampling and Analysis of Wash Water from Production Equipment