• Objective :

To lay down a Procedure for Trend Analysis.

•   Scope :

The scope of this document is to provide the Procedure for Trend Analysis of but not limited to Water analysis results, Environmental monitoring results, in Quality Control Department.

•    Responsibility :

•      Quality Control Personnel  :

•       To prepare the trends of results.

•      To review the trend analysis results.

•       To determine the Alert and Action Limits.

•       Head – Quality Control :

To review and monitor procedure for Trend Analysis.

•      Head – Quality Assurance :

To review and approve Trends.

•     Definition(s) :

Trend: A statistical term referring to the direction or rate of change of a variable(s).

•    Procedure :

•   Trend analysis shall be carried out as per requirement.

•  Trend Analysis shall contains Month, Year, Sampling point Id, Area name, Room number, Sampling frequency, Standard Test procedure number, Specification limit, Alert limit & Action limit etc.

•   Trend shall be prepared for individual tests and sampling point for water and individual room for environmental monitoring.

•  Plot the graph of the trend results test wise and review the same against the data for correctness.

•    The trend is applicable to parameters as given in table in point 5.6.

• Table for Trending parameters and frequency

Sr. No.	Type of Study	Parameters	Frequency
1	Potable water	pH , TVC	Monthly Roll on Basis
2	Purified Water	pH, Conductivity, TOC, TVC	Monthly Roll on Basis
3	Environmental Monitoring of Microbiology Testing Area by Settle plate	TVC	Monthly Roll on Basis
4	Environmental Monitoring of Microbiology Testing Area by Air sampling	TVC	Monthly Roll on Basis
5	Environmental Monitoring of Microbiology Testing Area by Surface Monitoring	TVC	Monthly Roll on Basis
6	Environmental Monitoring of Manufacturing Area ( Functioning Area ) by Settle plate	TVC	Quarterly Roll on Basis
7	Environmental Monitoring (Non  Functioning Area )  by Settle plate	TVC	Yearly
8	Environmental Monitoring  of Manufacturing Area by Air sampling	TVC	Yearly
9	Environmental Monitoring  of Manufacturing Area by Surface Monitoring	TVC	Yearly
10	Microbiological monitoring of Compressed Air	TVC	Yearly

• The trend analysis can be performed for other tests as per requirements.

• For the above studies, the trend results shall be made for daily acquired data during validation period or as and when required.

• Prepare the trends as per the table in point 5.6.

• Trend shall be prepared by user, reviewed by Head of the department or designee and approved by Quality Assurance.

• All trends shall be reviewed for its correctness and provided with the remarks. Out trend/ out of specification or absence of data other then the frequency as mentioned in respective SOP shall be reported with reference of QMS documents (e.g. change control, deviation etc.).

•  Distribution :

   This SOP (Controlled Copy) shall be distributed to Quality Control Department.

• Annex(es) :

Annex No.	Title
Annex – 1	Template of Trend for Water
Annex – 2	Template of Trend for Environmental Monitoring

      Abbreviations :

TOC : Total Organic Carbon

TVC  : Total Viable Count

QMS : Quality Management System

SOP : Standard Operating Procedure

 Reference(s) :

Nil

• SOP Revision History Record :

Revision No.

Details for Revision(s) with Change Control No.

Effective Date  (Sign. / Date)

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