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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
5.1.1.2 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.
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16.08.2019 SOP for Preparation of Trends : Pharmaceutical Guidelines
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
6.0 ABBREVIATION
6.1 SOP – Standard Operating Procedure
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read
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