The purpose of this SOP is to lay down the procedure for reporting, initiation, review, approval, compliance and closing of Laboratory incident.
This SOP is applicable for reporting, initiation, review, approval, compliance and closing of Laboratory incident Which occurs in Quality Control laboratory at the manufacturing facility.
- Quality Control Analyst/ Head / designee Quality Control shall ensure the appropriate Procedure is followed the reporting of laboratory incident in the quality control.
- Head – QC / designee shall be responsible for the step wise investigation, conclusion & corrective and preventive action.
- Quality Assurance shall be responsible for the Closing of Laboratory incident after the satisfactory completion of corrective and preventive action.
- Definition: A laboratory incident shall be defined as unplanned or uncontrolled event in the form of non compliance from the designated system, Instrument or procedure at any stage of analysis due to system failure or instrument malfunction or manual error.
- Whenever any incident occurs in laboratory during analysis, handling of instrument or method not followed shall be reported by the concerned analyst to Head-QC / designee.
- The incident form shall issue from the Quality Assurance. Authorized designee of QA shall log the incident in the relevant incident log.
- Reference number shall assigned for the incident occurred in the laboratory as mentioned below :
QC : Quality Control
LIR : Laboratory Incident Report
YY : Sequential number of the Incident
E. g. : QC/LIR/22/001 indicate first incident of the year 2022.
- As and when the occurrence of Laboratory Incident, the analyst shall record the Description of the Incident, the section head and QC head or designee shall evaluate the assessment of the unusual happening and based on nature of incident the immediate supervisor shall carry out the investigation.
- Operating staff who can understand English but have difficulty in expression of the English language in form of writing, may write the incident proposal and recommendations in vernacular. However, either the related department head or the QA shall redraft the same in English for the suitability of review by customers / regulatory agencies or auditors.
- All relevant operations / documents / procedures which give information about the cause of incident shall be investigated to find out the root cause of incident.
- Evaluated the probable causes and summarize to conclude to conclude and identify the root cause.
- The immediate corrective actions shall be completed before release of the batch if in case any incident is associated with a batch.
- QC head / designee shall decide the corrective action to avoid the recurrence of the incident and the same shall be recorded in the Annexure-II.
- All incident reports shall be investigated within 15 working days, unless otherwise justified.
- The documentation shall include sample details, methodology, incident detail, immediate action, investigation details, conclusion, recommendation, corrective action and preventive action as per Annexure-II
- If out of specification results obtained during the Incident investigation then the investigation shall be routed via the Out of Specification standard operating procedure (QA016).
- The raw data generated before occurrence of incident shall be disregarded, and shall be maintained with raw data.
For example, following types of data but not limited to,
Report print outs
Instrument failure during analysis
- All invalidated data shall be shall be stamped as ‘Disregards’ and sign by analyst / Designee the original data shall be attached with analytical report, photocopy of analytical data shall be attached with incident report.
- The reference incident number shall mention in the worksheet for the document and incident tracking.
- The laboratory incidents must include any of the following occurrences but not limited to :
Analyst oversight or error
System failure / Power failure
Spill out of sample, material, solution.
- Instrument malfunctioning:
- The analyst shall be performed by alternatives if there is any instrument malfunctioning during the analysis. The instrument shall be checked to find out the cause for malfunctioning. Instrument shall be used if found satisfactory and if not then it shall be identified as out of order till it get rectified and repaired.
- Analyst oversight or error:
- The analyst oversight / error contains such as weighing error, dilution error, programming error, sample and standard preparation mix up, analysis not carried out as per standard procedure etc.
- If the analyst has made an observable error (prior to result generation), Section In charge shall be consulted. This situation shall be documented in the Analytical record.
- In case of entry missing for instrument usage, working and reference standard, column usage entry, temperature recording etc. which does have direct impact on analytical results shall be addressed through the Laboratory incident procedure and analyst shall retrain to avoid reoccurrence.
- System failure / Power failure:
- In case of the System failure / Power failure due to following reason but not limited to.
- System suitability failure, unwanted peaks observed in chromatograms (apart from peak due to blank, mobile phase, placebo and diluents).
- The investigation shall be not applicable for System Check Injection. The same shall be disregarded. The obtained chromatographic data shall invalidate by using disregard stamps.
- If system suitability parameters failure noticed in the sample set run, then incident shall be logged and shall be investigate. Investigate the cause of failure, then accept the data if justifiable or proceed for new system suitability and repeat the analysis using original solution (if solution are within the solution stability period).
- In case of vial skipping server problems, system discontinues due to back pressure, power failure etc then log an incident and investigates to find out the cause. Repeat the using original solution (if solution are within the solution stability period).
- Spill out of sample, material, solution:
- In case of spill out of sample, material or solution during analysis, inform the immediate supervisor, routed through the Laboratory investigation procedure, disregard the sample weight print outs and prepare it again with permission of QC Head / Designee.
- Incident should be closed normally within 30 working days. In case this is not done, the initiator department has to submit justification with the approval of head QA.
- Authorized designee of QA shall check the status of incident and put their signature in incident log.
- Product specific incident should be closed before release of batch. Copy of the incident should be preserved with raw data sheet.
- Trend Analysis:
- Trend Analysis of incident should be performed in start of the next year by the QA department in the calendar year (January – December) .
- Product specific Incident shall be preserved up to expiry + 1 year or 05 year whichever is earlier.
- Product specific incident shall be listed in APQR.
Trainer : Head Quality Control
Trainees : All Department / Section Heads of QC & QA
Controlled Copy No.1 : Head of Department – Quality Assurance
Controlled Copy No. 2 : Head of Department – Quality Control
Original Copy : Head – Quality Assurance
- ANNEXURE(S) :
Annexure I : Incident Investigation Form
Annexure II : Incident Log
Annexure III : Trend Analysis of Incident
- REVISION HISTORY:
|Change Control Number
|Details of Revision
|Reasons(s) for Revision