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

Standard operating procedure of investigation in case when microbiology result of Environment monitoring reported out of Action level.


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


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


3.1 Doing : Technical Assistant
3.2 Checking : Executive/Manager


Head of the Department


5.1 On observation of out of action level limit of any environmental monitoring count, proceed for identify the organisms and inform to Q.C. Incharge immediately.
5.2 Q.C.In charge will immediately inform to 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 action level.
5.5 The product manufactured in the area will be hold 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 specific reason, the trend should be checked for further action plan by Q.A. /Production head/Q.C.


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

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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