SOP for Preparation of Trends

1.0 PURPOSE

To lay down the procedure for the preparation of trends.

2.0 SCOPE

This is applicable for Water Analysis results, Environment Monitoring Results, Microbial limit test Results.

3.0 RESPONSIBILITY

Microbiologist

4.0 ACCOUNTABILITY

Head of Department

5.0 PROCEDURE

5.1 The trends shall be prepared for the following test Results
1. Water Analysis results
2. Environment Monitoring Results
3. Microbial limit test Results

5.1.1 Water Analysis Results Trend

5.1.1.1 The trend for water analysis results shall be prepared for the following type of Water

S. No.	Type of water	Parameters
1	Raw water	pH, Hardness, Microbial count, Coliforms
2	Potable water	pH, TDS, Microbial count, Coliforms
3	Drinking water	pH, Microbial count, Coliforms
4	Soft water	Hardness, Microbial count
5	RO water	Hardness, Microbial count
6	Purified water	pH, Conductivity, TOC, Microbial count
7	Water for injection	pH, Conductivity, TOC, Microbial count
8	Pure Steam	Conductivity, TOC, Microbial count

5.1.1.2 The daily-acquired data of each parameter for each sampling point shall be taken for trend on a real-time basis.
5.1.1.3 Trend results shall be reported every month in a cumulative form for all sample results/ locations.
5.1.1.4 The monthly report shall contain the results of the current month and also it must contain cumulative data of the previous dates for the year.
5.1.1.5 To draw a meaningful conclusion, from the acquired data, all the results shall be subjected to the basic calculations, (But not limited to these) minimum, maximum and average (mean) and Standard deviation from mean shall be determined.
5.1.1.6 For all the statistical results shall be reported for the current month and cumulative period/ year till date.
5.1.1.7 If any data is crossing the limit determined, then the comments must be given in the respective trend.
5.1.1.8 The data obtained can be used in the establishment of alert and action limits or in-house specifications.
5.1.1.9 An annual summary report shall be prepared for the data obtained for the entire year.
5.1.1.10 The report shall at least contain the following Table of Contents.
• Approval Signatures
• Objective
• Methods
• Procedure
• Schedule for Environmental monitoring
• Recommended limit
• Locations for Environmental monitoring
• Summary of the Environmental monitoring result
• Summary
• Contamination rate
• Deviation
• Conclusion
5.1.1.11 The unique document no. for the annual Summary Report shall be given as follows
AT/EM/XXX
Where,
AT stands for the code for Annual Trend and is fixed.
EM stands for the code for Environment Monitoring and is fixed.
XXX stands for the serial number, which starts from 001.
5.1.1.12 This annual summary shall consist of maximum readings of the year and minimum readings of the year.
5.1.1.13 This summary may be used for establishment of seasonal variation or to revise existing alert and action limits.
Related: 3-Sigma Formula for Trend Analysis Limits

5.1.2 Environment monitoring Results Trend

5.1.2.1 The trends for environmental monitoring results shall be prepared for the production facilities and microbiological testing facility.
5.1.2.2 The trend shall be prepared for the parameters mentioned in their respective SOPs and the data acquired against the parameters.
5.1.2.3 As mentioned in point No. 5.1.1.3 to 5.1.1.9 the data shall be plotted as a trend and the same shall be reviewed for its correctness and the CAPA required if any.
Related: Difference Between Out of Specification and Out of Trend

5.1.3 Microbial limit test Results

5.1.3.1 The trends for Microbial Limit Test Results of Raw Material and finished products shall be prepared for ”Total aerobic microbial count” and “Total yeast and mold count”.
5.1.3.2 The data acquired for the entire year shall be trended for each product.
5.1.3.3 As mentioned in point No.5.1.1.5 to 5.1.1.7 trend shall be prepared.
5.1.3.4 Annual trend summary shall be prepared for environmental monitoring program and water analysis program. It shall be completed before the end of the first month of the subsequent year. It shall be, duly approved by Quality assurance department.

6.0 ABBREVIATION

6.1 SOP – Standard Operating Procedure

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