SOP for Investigation for Out of Action Level Results of Monitoring of Microbiological Environment

1.0 OBJECTIVE

To lay down the procedure for investigation in the case when microbiology result of Environment monitoring reported out of Action level.

2.0 SCOPE

This procedure is applicable to parenteral manufacturing area and laboratory where environmental monitoring is carried out by a different method.

3.0 RESPONSIBILITY

3.1 Doing: Technical Assistant
3.2 Checking: Executive/Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

5.1 On observation of out of action level limit of any environmental monitoring count, proceed to identify the organisms and inform to Q.C. Incharge immediately.
5.2 Q.C.In charge will immediately inform Q.A. head and Production head.
5.3 The manufacturing activity in the area will be suspended till corrective actions are found satisfactory.
5.4 On consultation with Q.A. head and production head will jointly decide investigation plan of the area including surrounding area where the count observed above the action level.
5.5 The product manufactured in the area will be held by Q.A. till detailed investigation report.
5.6 The corrective action will be implemented and monitored by Q.A. & Production head.
5.7 Area will be monitored for 3 days to evaluate the results of corrective action taken.
5.8 If results are within the limit then convey the results to production head.
5.9 If on investigation it is found that out of action level results is recurring due to a specific reason, the trend should be checked for a further action plan by Q.A. /Production head/Q.C.

6.0 ABBREVIATIONS

Q.C. =Quality Control.
Q.A. =Quality Assurance

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