Handling of Laboratory Incident in Pharma

Laboratory Incident: Any unintentional/ unexpected event that occurs during analysis, discovered during analysis, and after analysis that may adversely affect the data quality and the result.

Types of common Laboratory Incidents:

1. Human errors: e.g., Wrong weight taken, the wrong solution prepared, wrong selection of instrument method, and lack of training.
2. Instrument errors: e.g., system suitability failure, standard bracketing failure, column leakage, connectivity failure, and power failure.
3. A standard error also includes Method errors: e.g., Poor column performance, diluent or mobile phase ratio, and distorted peak.

Type of Lab incident:

Types of labs incident may include general incidents and Instrumental errors:

General incident:

1. Is the sample taken wrongly?
2. Lack of knowledge of the person who is working in a laboratory
3. Error in standard sample preparation
4. Weighing error happened
5. Error in diluent volume/ or diluent used
6. Glassware breakdown during the standard solution process.
7. Error with the mobile phase or maybe a mixing error
8. Error in pH management
9. HPLC/ GC handling
10. Power failure during instrument operation
11. Wrong injection volume injected

Instrumental error:

1. Use out-of-calibrated instruments.
2. Failure of lamp intensity
3. Column Leak, Poor Plate Count, Poor Resolution
4. It may be a Connection problem between the software and Instrument.
5. The wrong specification selected in LIMS was observed while registering Product brand/material before product/material release.
6. A Chromatographic peaks failure between the sample subset.
7. Improper separation (merging the components) was observed in chromatograms during the chromatographic analysis.
8. System failure was observed during the analysis because of column’s high pressure/ Instrument.
9. End value may affect calculation errors or false reporting observed after the release of materials/products.
10. In case of bracketing of standards in assay, content uniformity, dissolution, dissolution profile, and deviation from specified limits.
11. It may be due to Calibration failure during the quarterly/daily calibration procedure.

Flow Chart for How to Handle Laboratory incident

Procedure for Lab incident event:

1. When an analyst obtains atypical results or becomes conscious of laboratory or procedural errors committed during testing, he or she will annotate the atypical results or known laboratory errors within the appropriate lab logbook.
2. Inform to laboratory supervisor, and initiate filling out the Laboratory Logbook
3. The investigation report ensures that all the starting, solvents, and intermediate materials are properly preserved all solvents, Investigation reports also include intermediate and final solution standards used in the testing.
4. These materials will be retained and preserved until the completion of the investigation or until they are no longer helpful. Laboratory investigations will be initiated within one business day of discovering the OOS/atypical result. They will be completed within 15 business days unless the extension is approved in writing by the laboratory supervisor and QA.
5. The supervisor immediately reviews the results, the lab logbook, starting materials, all solutions, the raw data, and the calculations used to generate the final results. A laboratory investigation report error review is completed using the report Errors Checklist (a blank Errors Checklist is an attachment to the Guidelines used in each factory).
6. The checklist will be completed by the supervisor and analyst together. The supervisor will interview the analyst and can check relevant documents in order to answer questions that can help identify whether common or obvious laboratory errors were the basic explanation for the OOS/atypical result.

These questions will include the following, provided as examples, and not intended to be inclusive:

1. Was the analyst trained on the test method?
2. Was the latest version of the method used?
3. Was the proper test method being used?
4. Was the test method procedure appropriately followed?
5. Does the logbook documentation indicate any procedural errors were made?
6. Does the review of the starting materials, solvents, solutions, and glassware
7. Does the laboratory work area indicate any gap?
8. Was the sample used during the process correctly?
9. Was the sample spilled or contaminated before testing?
10. Ensure proper standard reference solution was prepared and used.
11. Is the laboratory area under environmental control (for example, (Temperature and humidity)?

Also read: calibration of UV-Visible spectrophotometer

Note: Incident Trends also required to be analyzed so that it becomes easy to find the type of incidents that happened before and their frequency.

Laboratories incident form no. (Annexure-1)

Incident Checklist point :