SOP for OOS results in Environment Monitoring

SOP for OOS results in Environment Monitoring

Environment monitoring is a regular process in a pharmaceutical manufacturing company in the manufacturing area and quality control department. There are some specifications followed for environmental conditions allowed in the specified area. If the results during microbiological testings for environment monitoring found out of specification that called OOS results. The environment monitoring test is performed according to the SOP made for that. If the results do not found satisfactory then a corrective action plan should apply according to the SOP for OOS results in environment monitoring.


1.  Objective: To lay down a procedure for Investigation of the OOS results in environment monitoring.

2. Scope: The procedure of this SOP will be applicable to the Microbiology Department of XYZ Pharma Company.

3.           Responsibility :         Microbiologist Chemist

4.           Accountability  :       Q.C. Manager

5.           Abbreviations :             

S.O.P.    :    Standard Operating Procedure

QC         :    Quality Control

QA         :    Quality Assurance

6. Action Steps :  

6.1 If the CPU counts exceed the Alert / Action levels at any location any day in the samples taken from the Environment or Personnel, the Production Head & QA Manager will be instantly informed by QC Department with a dully-filled “Action Taken Report Format”.

6.2 The Action Taken Report Format shall contain the following details.

  1. Name of the Area.
  2. Date of monitoring
  3. Sampling method used
  4. Sampling location
  5. Microbial count exceeds Alert / Action limit
  6. CFU observed
  7. Action limits

6.3 Investigation will be carried out in both the Quality control & Production department simultaneously.

6.4 Quality Control Department

  • The Results will be discussed with the Microbiologist for any unusual observations made in the area and for any difficulty faced during sampling.
  • Media Preparation & Sterilization Records and Negative controls of the Media will be checked for any abnormity.
  • Identify the organism up to possible level from the plate showing O.O.S. result.
  • Identify the organism isolated from other places which are having the same colony characteristics to establish the possible source of contamination.
  • Document the historical review of environmental monitoring results for the site in question.
  • If the above observations do not confirm as a cause of analytical error then check at the production department.
  • Production Department.
  • The investigation will be carried out as per the checklist given in the Annexure the SOP.
  • The QA Head will investigate the cause of the O.O.S. results in co-ordination with the Microbiology section (Q.C.) and Production Head.
  • After investigations are over the Plain manager will send duly filled action taken report along with the investigation report to Q.C. 
  • O.O.S. Investigation for Alert level.
  • The alert level can consider as an “early warning” of potential drift from normal operating conditions and it allows the corrective actions to be taken before product quality is adversely affected.
  • Document the previous results for the affected site to determine the possibility of unfavorable and developed.
  • Upon review of the above-determined results, further investigation and/or additional sampling can be warranted. Instruct the in-charge (Operation in the clean area) to take extra measures for the disinfection of the site in question.
  • O.O.S. investigation for Action Level.
  • If there have been multiple excursions in excess of alert level or it the action level has been exceeded investigate the parameters shown.
  • On the basis of the investigation made as per, establish the corrective action required and implement it.
  • After the corrective actions are taken check the effectiveness of these actions by suitable monitoring.
  • If the count exceeds alert/action level for Operator glove or gown check the following parameters :
  • Operator activity
  • Environment monitoring history of the operator.
  • Other environmental monitoring data in the working area.
  • Periodic sanitization for groves.
  • Types of organisms identified.
  • Operator’s validation data during media fill.
    1. Take the actions as mentioned in Step No. 4.21 to 4.23 for product release action. Also, instruct the in-charge for the requalification of the operator and give and adequate training to the operator.


  • SOP NO. QA 277 
  1. DATE OF O.O.S RESULTS                  :
  2. FACILITY                                               :
  3. SAMPLE DETAILS                               :
S. No.Parameters CheckedAccep. LimitObservationsRemarks
2.Relative Humidity   
3.Differential pressure of area   
4.Manometer reading of L.A.F.   
5.HEPA integrity checked last time on an result   
6.Cleaning & Disinfection of the area   
7.Disinfectant preparation date   
8.Cleaning & Disinfection of the area   
9.Any Deviation observed during batch manufacturing   
10.Last fumigation recorded on   
11.Visual observations of the Area for any Abnormalities   
12.Any Power failure on that day If yes, mention duration   
13.Maintenance record for any recent activity in area   
14.Historical review of environmental monitoring for the site in question   
15.Identification of organisms and comparison with organisms isolated from other site to determine source   
16.No. of persons working in area   
17.Personnel monitoring results if not satisfactory, give details   
18.Possible source of contamination with justification   
19.Reason for O.O.S.   



QC – Microbiology Lab.


The In-charge Production / In-charge Q.A.


Find here the details of the environmental monitoring results, showing CFU exceeding the Alert / Action levels :

Date of Monitoring                         :

Sampling method used                    :

Location showing high counts        :

Alert limits                                      :

Action limits                                   :

Please investigate the matter and return the duly filled A.T.R. format to Q.C.

(Microbiologist)        (In-Charge Microbiology)                            (Q.C. In-Charge)

FROM                                                                                                       DATE :


On the basis of investigations made as per following actions were taken :

(Chemist – Production)                       (In-Charge Production)

7.0                 Recommended Distribution:

S. NoDepartmentDistribution [Yes / No]
01 Microbiology sectionYes

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Darshan Singh

The author has 20 years of experience in the Pharmaceutical Manufacturing Companies. Have exposure to all audit documents for WHO-GMP, PIC/S, USFDA, Export documents, US-FDA documents, Validation of Pharma machinery, and Quality Control Instruments. Expert in Pharma Plant Setup and sale and acquisition of running pharma company.
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