SOP for Handling of a Laboratory Incident : Pharmaceutical Guidelines

SOP for Handling of a Laboratory Incident

Standard operating procedure to handle the laboratory incidence in pharmaceutical quality control.

1.0 OBJECTIVE

To lay down the procedure for the handling of a laboratory incident in the Quality Control.

2.0 SCOPE

This SOP shall applicable to the Quality Control Laboratory.

3.0 RESPONSIBILITY

3.1 Doing: Officer/ Sr. Officer
3.2 Checking: Executive/ Manager

4.0 ACCOUNTABILITY

Head of the Department

5.0 PROCEDURE

The source of lab incidents includes the following examples:

5.1 General Incidents:

5.1.1 Borderline results
5.1.2 Tested for the parameter other than given in the specification.
5.1.3 Mistake in the calculation and reporting.
5.1.4 Any contamination during the sample, standard preparation, and storage of sample.
5.1.5 Usage of instruments like analytical balance, pH meter, conductivity meter etc. before calibration etc.
5.1.6 Deviation in weighing, dilutions and standards etc.
5.1.7 Wrong entry of method parameter, sequence etc in the software.
5.1.8 Improper sample handling during analysis.
5.1.9 Glassware breakage having sample or standard.
5.1.10 Discontinue analysis for electrical problems or due to urgent re-planning of work.
5.1.11 Sample spills during the LOD, Sulphated Ash or Moisture Content.
5.1.12 System suitability parameter failure.

5.2 Chromatography:

5.2.1 Injection carryover
5.2.2 Additional / unknown impurities
5.2.3 Any shift in RT / RRT (NMT 10 %)
5.2.4 Improper peak shape and peak splitting
5.2.5 Baseline drift
5.2.6 Bracketing standard does not meet acceptance criteria

5.3 Spectroscopy:

5.3.1 Extra peaks in the spectrum
5.3.2 Low Correlation with standard spectrum

5.4 Microbiology:

5.4.1 OOT and borderline results
5.4.2 TOC baseline noise
5.4.3 Wrong media preparation by mistake
5.5 Entry missing in instrument log book
5.6 Based on the sound scientific principles, analyst shall discontinue testing and immediately notify supervisor or designee if an incident, problem or error is suspected or recognized.
5.7 All incidents shall be logged as per respective annexure. 
5.8 The incident report number shall be assigned as QCI/YY/XXX,
Where, first three characters ‘QCI’ stand for Quality Control Incident. The fourth character is ‘/’ fifth and sixth characters YY stand for the year (‘08’ for the year 2008). The seventh character is ‘/’ eighth, ninth and tenth characters are serial no. starting from 001. Serial no will start from 001 for every year.
5.9 The analyst/reviewer shall write the brief of an incident in the laboratory incident report as per respective annexure and shall attach all relevant data with the report.
5.10 When an incident has been observed during analysis on HPLC or GC, analyst shall fill checklist as per respective annexure in the case of HPLC and as per respective annexure in the case of GC as a part of the investigation.
5.11 QC Manager shall review the report and shall recommend the corrective or preventive action plan based on the investigation. 
5.12 QA Manager shall approve the incident report.
5.13 Any laboratory incident observed shall be logged within one working day of discovery of a discrepant laboratory and incident investigations shall be closed within thirty working days from the date incident is reported. The reasons for any extension will be documented.
5.14 All personnel involved in the investigation process from identifying a discrepant laboratory test result through record retention of such an event shall be properly trained to perform assigned tasks.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 STP: Standard Testing Procedure
6.3 QC: Quality Control
6.4 QA: Quality Assurance
6.5 HPLC: High-Performance Liquid Chromatography
6.6 GC: Gas Chromatography
6.7 TOC: Total Organic Carbon

Annexure I

Name of Product:
B.No/A.R.No:
Equipment Involved:
Incident Report No:
Test:
Date of Analysis:
Name of Analyst:
Date of Incident:
Spec No:
STP No:
Description of Incidence:




Analyst:


Sign/Date:
Reviewer:


Sign/Date:
Investigation:




Analyst:


Sign/Date:
Reviewer:


Sign/Date:
Proposed Corrective Action:






Reviewer:


Sign/Date:
Head QC:


Sign/Date:
Corrective Action Taken:




Analyst:


Sign/Date:
Reviewer:


Sign/Date:
Preventive Action Taken (If any):




Head QC:


Sign/Date:
Head QA:


Sign/Date:







Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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