SOP for Evaluation of Environmental Monitoring Results (Trend Analysis) : Pharmaceutical Guidelines

SOP for Evaluation of Environmental Monitoring Results (Trend Analysis)

Standard operating procedure to evaluate the environmental monitoring results of different area by trend analysis.

1.0  Objective

       To  ensure the corrective action to be taken for the result exceeding alert & action level.

2.0  SCOPE

       This procedure is applicable to evaluate the environmental monitoring results of different area by trend analysis.

3.0  Responsibility

3.1  Doing      : Technical Assistant (Microbiologist)
3.2  Checking : Executive/Manager    

4.0  Accountability

       Head of the Department

5.0  Procedure

5.1  Distinguish  the results in three categories as follows.
       1. Normal level
       2. Alert level
       3. Action level
5.2  No action is required for results observed in normal level and below alert level category.
5.3  Consider the results, observed above normal level and below action level as alert level category.
5.3.1  On alert trend of results inform to Q.A and Production department.
5.4  Initiate the preventive action for any action level or critical results .
5.4.1  In action level results, a deviation report must be submitted to Production, Q.A and Quality control (Microbiological testing lab) and to be involved in deciding action to be taken.
5.5  Evaluate the results and decide that  up to what extent and how much identification is relevant based on comments from production. Identify all micro organisms found in the critical areas up to a level for  determining the origin of the same.
5.6  Send the trend analysis report to QA dept. for evaluation of trend.
5.7  Frequency of trend analysis
 Location                                                                                                         Frequency
 Surface samples and air samples in class 100 and 10,000 area                         Once in week
 Surface samples and air samples in class 100,000 area                                     Once in quarter   
 Finger print and gown of personnel working in Green Area                               Once in quarter     
 Settling plate in solid dosage area                                                                     Once in quarter
 Settling plate in Raw material dispensing and sampling booth                             Once in quarter
 Surface sample and air samples in 100 and 10,000 area                                   Once in a month
 In sterility room and inoculam room in microbiology laboratory                         Once in a month
 Settling plate in sterility testing and inoculation room microbiology lab.              Twice in a month
 Finger print and gown of person working in sterility                                          Once in quarter 
 Inoculation room and non viable particle count in microbiology lab                    Once in quarter 

6.0  Abbreviations 

6.1  Q.A = Quality Assurance
6.2  Lab. = Laboratory

Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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