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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 trend report once a week 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 action level in the graph.
  • The water system is considered satisfactory for its quality of output If 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

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