sop for for Laboratory Incident

1.0 OBJECTIVE:
To lay down a procedure for Laboratory Incident.

2.0 SCOPE:
This SOP is applicable of procedure for Laboratory Incident in quality control department

3.0 RESPONSIBILITY:
Executive/Officer QC/designee.

4.0 ACCOUNTABILITY:
Head- Quality Control

5.0 PROCEDURE

5.1 Standard Practices:

5.1.1 During analysis before reporting if Incident found as per points listed below shall be considered as Laboratory Incident and Incident shall be logged in Annexure-I and filled in Annexure – II of the SOP.
5.1.2 Following points shall be considered in Laboratory Incident.

5.1.3 General Incident :

5.1.3.1 Borderline results due to analyst error or Instrument error.

5.1.3.2 Tested parameter other than given in specification.

5.1.3.3 Mistake in calculation and or reporting.

5.1.3.4 Any contamination during sample / standard preparation / storage of sample.

5.1.3.5 STP deviation with respect to weighing, dilutions, standards etc.

5.1.3.6 Improper sample handling during analysis.

5.1.3.7 Glassware breakage with sample or standard.

5.1.3.8 Discontinue analysis for electrical problems, urgent re-planning of work.

5.1.3.9 Entry missing in instrument/other respective log book.

5.1.4 Chromatography

5.1.4.1 Injection Carryover

5.1.4.2 Shift in Retention Time / Relative Retention Time (Not more than 10 %)
5.1.4.3 Improper Peak Shape and Peak Splitting

5.1.4.4 Baseline Drift

5.1.4.5 Bracketing standard does not meet acceptance criteria.

Note: In case if complete batch table run and chromatogram obtained then above points shall be considered as laboratory Incident.
5.1.5 Spectroscopy:

5.1.5.1 Extra peaks in the spectrum

5.1.5.2 Low Correlation with standard spectrum

5.1.6 Microbiology:

5.1.6.1 Wrong media preparation

5.1.6.2 Other unplanned unwanted event.

5.1.7 Instrument malfunctioning

5.1.7.1 Column Issue

5.1.7.2 Software malfunctioning

5.1.7.3 Power Failure

5.1.7.4 Hardware Error

5.1.7.5 Leak Detection

5.1.7.6 Communication error

5.1.7.7 Frit / Cartridge choke

5.1.8 Analyst Oversight

5.1.8.1 Wrong material

5.1.8.2 Wrong glassware

5.1.8.3 Glassware cleaning

5.1.8.4 Instrument out of calibration

5.1.8.5 Reviewer oversight

5.1.8.6 Entry error

5.1.8.7 Sample / Standard preparation error

5.1.8.8 Sample spillage during the analysis

5.1.8.9 Wrong sequence on instrument error

5.1.9 Based upon sound scientific principles, analyst shall discontinue testing and immediately notify

supervisor or designee if an incident, problem or error is suspected or recognized.
5.1.10 Allocation of Analytical reference number for Laboratory Incident:

5.1.10.1 Laboratory Error shall be given the specific number as QC/INC/XX/YYY, where ‘XX’ shall be for year and ‘YYY’ shall be Serial number as ‘001.
Where is QC for Quality Control, INC for Incident, XX for current year and YYY shall be Serial number as ‘001. (e.g. QC/INC/21/001)
5.1.11 In case of Laboratory Incident conforms before reporting OOS shall be not applicable.

5.1.12 In Investigation no any Probable /Root cause identified OOS shall be applicable

5.1.13 All Incidents shall be logged by QC dept. as per respective Annexure.

5.1.14 After Investigation with corrective action & Preventive action, analysis repeat the sample.

5.1.15 Conclusion of QA Head shall be completed after re-analysis the sample and observed the result.

5.1.16 If any Chromatogram system suitability parameters does not complies or any discrepancy in running system been detected online,

the same should be made invalid and maintain the record as per Annexure-III
5.1.17 PROCEDURE FOR DATA INVALIDATION: Data shall be invalidated in the following cases when any of the below error may identified online:-
5.1.17.1 Wrong Batch Table

5.1.17.2 Peak Splitting

5.1.17.3 System suit failure at any injection

5.1.17.4 Improper peak shape

6.0 ABBREVIATION:

Ltd. :Limited
SOP : Standard Operating Procedure
No. :Number
QC :Quality Control
QA :Quality Assurance
STP :Standard Operating procedure
RSD :Relative Standard Deviation
HPLC :High Performance Liquid Chromatography
TOC :Total Organic Carbon

7.0. ANNEXURES:

ANNEXURE No.	TITLE OF ANNEXURE
Annexure-I	Laboratory Incident Log Book
Annexure-II	Laboratory Incident Form
Annexure-III	Inward for Invalid Documents

8.0 DISTRIBUTION:

Controlled Copy : Quality Control Department
Master Copy : Quality Assurance Department

9.0 REFERENCES:

In House

10.0 REVISION HISTORY:

Revision No.	Change Control No.	Details of Changes	Reason of Changes	Effective Date	Done By
00	Not Applicable	Not Applicable	New SOP

ANNEXURE-I

Laboratory Incident Log Book

Date

Incident No.

Product/ Material Name

Batch No.

Name of Analyst

Description of Incident

Initiated by

Checked by

Rem ark

ANNEXURE-II

Laboratory Incident Form

ANNEXURE – III

INWARD FOR INVALID DOCUMENTS

S. No.	Date	Product/ Material Name	Batch No/AR No.	Instrument Name/ID	Reason for Invalid	Corrective Action	Analyst Name	Checked By/Date	Remarks