Handling of Laboratory Incident in Pharma

Laboratory Incident: Any unintentional/ unexpected event that occurs during analysis discovered during analysis or after analysis adversely affects the data quality or representativeness and affects the result.

Types of common Laboratory Incident:

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

Type of Lab incident error:

General incident:

  • Is the sample taken wrongly?
  • Lack of knowledge in laboratory person
  • Error in standard sample preparation
  • Weighing error happened
  • Error in diluent volume/ or diluent use
  • Glassware breakdown having standard solution during the process.
  • Mobile phase and its mixing error
  • Error in pH management
  • HPLC/ GC handling
  • Power failure during instrument operation
  • Wrong injection volume injected

Instrumental error:

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

Flow Chart for handling Laboratory incident

laboratory incident

Procedure for Lab incident event:

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.

Inform to laboratory supervisor, initiate filling out the Laboratory Logbook

The investigation report ensures that all the starting materials, solvents, intermediate properly preserve all solvents, intermediate and final solution standards used in the testing.

These materials will be retained and preserved until completion of the investigation or until they are no longer helpful. Laboratory investigations will be initiated within one (1) business day of discovering the OOS/atypical result. They will be completed within ten (10) business days unless the extension is approved in writing by the laboratory supervisor and QA.

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 gross error review is completed using the Gross Errors Checklist (a blank Gross Errors Checklist is an attachment to Guidelines used in each factory).

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 (gross errors) were the basis explanation for the OOS/atypical result.

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

  • Was the analyst trained on the test method?
  • Was the latest version of the method used?
  • Was the proper test method being used?
  • Was the test method procedure appropriately followed?
  • Does the logbook documentation indicate any procedural errors were made?
  • Does the review of the starting materials, solvents, solutions, glassware, and
  • Does the laboratory work area indicate any gap?
  • Was the sample used during the process is correct?
  • Was the sample spilled or contaminated before testing?
  • Ensure proper standard reference solution used, and was it made properly?
  • Are the laboratory area is under environmental control (for example,
  • Temperature and humidity)?

Also read: calibration of UV-Visible spectrophotometer

Trending of the incident also required from which we observed which type of incident happens frequently and where we need to focus on control incidents in the laboratory.

Laboratories incident form no. (Annexure-1)

Incident Checklist point :