To lay down the procedure for Investigation of out of specification (OOS) results in Microbiology.
1.0Purpose:
To lay down the procedure for Investigation of out of specification (OOS) results in Microbiology.
2.0Scope :
This procedure is applicable to Investigation of out of specification (OOS) results in microbial testing of Non-Sterile Products, Water Samples, and Environmental Monitoring carried at Astrix Laboratories Limited, Kazipally.
3.0Responsibility:
3.1.The Microbiologist is responsible for reporting any out of specification results.
3.2.Head - Quality Control or his designee shall be responsible review and notify to QAD and initiate necessary investigation.
3.3.Head - Quality Assurance shall be responsible for review and approval of investigation report and identified corrective and preventive actions.
3.4.Head of concern department to participate in investigations and to implement necessary corrective and preventive actions.
4.0Definitions / Abbreviations :
HVAC : Heating Ventilation and Air Conditioning
LAF : Laminar Air Flow.
OOS : Out of Specification.
5.0Procedure :
Any Out of specification observed in microbial test results during analysis shall be reported in the following manner;
5.1 Immediately microbiologist inform to the immediate superior to check the results to reporting as OOS.
5.2 Immediate superior shall monitor the details and conform it as OOS, then take OOS global investigation notification form from QAD.
5.3 OOS numbering system shall be followed as per Investigation of out of specifications (OOS) results SOPxxxxx
5.4 The creation and documentation of investigation till closure shall be done as per the SOP of Laboratory investigation Report (LIR) (SOPxxxxx) in Trackwise software.
5.5 Out of specification shall be initiate through Trackwise and investigation followed as per the below procedures based on the OOS and attach the investigation report in Trackwise.
5.6Microbial testing of Products:
5.6.1Out of specification (OOS) results in the bacteriological testing may be due to high bacterial count and total fungal count or due to presence of any specified organism in the sample.
5.6.2Verify the results for negative control test performed along with the sample analysis. If the negative control result shows growth then the test can be considered as invalid.
5.6.3Review the preparation record of all media and diluent used in the test.
5.6.4Review the sterilization records of all the materials prepared and sterilized in the laboratory.
5.6.5Review the differential pressure, temperature and relative humidity records (if applicable) for any unusual results.
5.6.6Review the cleaning records of the laboratory and verify whether correct disinfectant and concentration is used and cleaning is performed as per procedure.
5.6.7Verify the test performing process and sampling activity as given below but not limited to:
5.6.7.1 The sample preparation and testing was performed as per procedure.
5.6.7.2 Whether sample was received in appropriate condition before testing.
5.6.7.3If any anomalies observed during any stage of testing and incubation.
5.6.7.4If the negative sample shows growth or if the out of specification can be conclusively attributed to Laboratory error, then test can be considered invalid and repeat the analysis.
5.6.7.5Evaluate the information gathered and if assignable root cause can be determined. Also evaluate the impact on other batches manufactured before and after the subject batch.
5.7Environment Monitoring :
5.7.1Out of specification (OOS) results in Environmental monitoring, check all the negative control of the media used for the environmental monitoring and also check the media preparation sterilization, growth promotion and pre-incubation records.
5.7.2Check the training records of the person who had performed environmental monitoring activity.
5.7.3In case, no deficiency during media preparation and environmental monitoring is observed, check the AHU filters cleaning records, periodic AHU qualification records, cleaning and fumigation records of the affected area.
5.7.4Inform to concerned personnel in affected area through QAD to initiate additional cleaning and sanitization of the area with approved disinfectant. Fumigation of the affected area can be additionally performed.
5.7.5After additional cleaning and sanitization of the affected area, perform environmental monitoring of the affected area for three consecutive days.
5.7.6In case out of specifications results, perform Gram staining of morphological similar colonies and identification of respective isolates based on Gram staining results as per SOPxxxxx
5.8Investigation of Out of Specification results in microbial analysis of water:
5.8.1In case of out of specification, check all the negative control of the media used for water analysis and check the media preparation, sterilization, growth promotion and pre-incubation records. Check the water sampling method.
5.8.2Check the results of the sample analysed simultaneously.
5.8.3Review the water trend.
5.8.4In case no discrepancy is observed in testing, inform plant engineering to sanitize the purified water system loop (hot water sanitization).
5.8.5After loop sanitization, analyze the affected sampling points for three consecutive days.
5.9Investigation of Out of Specification results in microbial analysis of presence of objectionable organisms in water:
5.9.1In case of out of specification, check all the negative control of the media used for water analysis and also check the media preparation sterilization, growth promotion and pre-incubation records. Check the water sampling method.
5.9.2If no discrepancy is observed during testing and water sampling, inform to QAD and Engineering department about the excursion.
5.9.3All products manufactured during Out of specification investigation, shall be tested for microbiology limit test. In case the microbial limit test is not meeting the specification, the product shall be rejected.
5.9.4Necessary actions shall be initiated in consultation with QAD & Engineering department.
6.0Related Documents:
6.1Laboratory investigation Report (LIR) SOPxxxxx
Investigation of out of specifications (OOS) results SOPxxxxx.
Microbiology, specification, investigation,
