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Medical Device Validation

Minimize wasted time &cost. Ensure a process for quality molds & parts

Home Quality Control SOP

SOP for Statistical Study for Trend Analysis of Purified Water and Water for Injection
Standard operating procedure to prepare the trend of Purified Water and Water for Injection.
Ankur Choudhary |

Quality Control | SOP

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Medical Device
Validation
Minimize wasted time
&cost. Ensure a process
for quality molds & parts

1.0 OBJECTIVE

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

This procedure gives guidelines for evaluating the results and to take corrective action if the results exceed 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 graph.
5.4 The water system is consider 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
6.2
6.3
6.4

SOP = Standard Operating Procedure

Q.A. = Quality Assurance
Q.C. = Quality Control
W.F.I = Water for injection

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Medical Device
Validation
Minimize wasted
time &cost.
Ensure a process
for quality molds
& parts

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ABOUT THE AUTHOR

Ankur Choudhary is experienced in
pharmaceutical, author and founder of
Pharmaceutical Guidelines, a widely-read
pharmaceutical blog since 2008. Email:
info@pharmaguideline.com
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