SOP for Evaluation of Environmental Monitoring Results (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 the 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 an alert level category.
5.3.1 On the 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 the 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 microorganisms 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
Fingerprint and gown 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 inoculum room in microbiology laboratory                   Once in a month
Settling plate in sterility testing and inoculation room microbiology lab.         Twice in a month
Fingerprint and gown of person working in sterility                                    Once in quarter
Inoculation room and nonviable particle count in microbiology lab               Once in quarter

6.0 Abbreviations

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

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