sop for for Laboratory Incident


sop for for Laboratory Incident



To lay down a procedure for Laboratory Incident.

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

Executive/Officer QC/designee.

Head- Quality Control



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 : Borderline results due to analyst error or Instrument error. Tested parameter other than given in specification. Mistake in calculation and or reporting. Any contamination during sample / standard preparation / storage of sample. STP deviation with respect to weighing, dilutions, standards etc. Improper sample handling during analysis. Glassware breakage with sample or standard. Discontinue analysis for electrical problems, urgent re-planning of work. Entry missing in instrument/other respective log book.

5.1.4 Chromatography Injection Carryover Shift in Retention Time / Relative Retention Time (Not more than 10 %) Improper Peak Shape and Peak Splitting Baseline Drift 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: Extra peaks in the spectrum Low Correlation with standard spectrum

5.1.6 Microbiology: Wrong media preparation Other unplanned unwanted event.

5.1.7 Instrument malfunctioning Column Issue Software malfunctioning Power Failure Hardware Error Leak Detection Communication error Frit / Cartridge choke

5.1.8 Analyst Oversight Wrong material Wrong glassware Glassware cleaning Instrument out of calibration Reviewer oversight Entry error Sample / Standard preparation error Sample spillage during the analysis 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: 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:- Wrong Batch Table Peak Splitting System suit failure at any injection Improper peak shape


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


Annexure-I Laboratory Incident Log Book
Annexure-II Laboratory Incident Form
Annexure-III Inward for Invalid Documents


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


In House


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

Laboratory Incident Log Book



Date Incident No. Product/ Material Name Batch No. Name of Analyst Description of Incident Initiated by Checked by Rem ark


Laboratory Incident Form



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


SOP for testing of ETP water

sop for Calibration and Maintenance of Laboratory Instruments and Equipment

Disposal of Residual Sample or Left Over Material

sop for for Laboratory Incident

standard operating procedure temperature monitoring

sop for drying of silica gel

sop for operation of infrared moisture balance

sop for preparation of mobile phase

sop for treated RO water

sop for Preparation and Issuance of Analysis protocol standard

sop of placebo and impurity stock solutions

sop for disposal of residual sample  

sop for handling of pharmacopoeial changes

sop for procedure for operation of ultrasonic cleaner

difference between UPLC and HPLC

sop for for Emergency Eyewash and Shower

sop for operation and calibration of total organic carbon analyzers

sop for operation of cobb tester

sop for Operation and calibration of atomic absorption spectrophotometer

sop for Operation and calibration of gas liquid chromatograph

sop for operation of humidity oven

sop for operation and calibration of serological water bath

sop for monitoring of drain trap

sop for destruction of analytical samples after testing and control samples

sop for destruction of used chemicals

Sop for Operation of suction pump

sop for Operation and calibration uv cabinet

sop for Operation and calibration of bulk density apparatus

sop for operation and calibration of shore hardness tester

sop for operation of rub proofness tester

sop for monitoring of purified water

sop for Retesting of packaging materials

sop for Retesting and resampling of raw materials

sop for Control of issuance of record of analysis green sheets

sop for Control of computer passwords

sop for sampling of packaging materials PM

sop for sampling of sterile raw material

sop for sampling of intermediates and finished products

sop for operation and calibration of friability test apparatus

sop for approval and rejection of packaging materials

sop for non conformance of RM PM and finished product

sop for collection storage and disposal of control samples

sop for trend analysis of finished products

sop for Chromatographic practices and system suitability

SOP For Good Laboratory Practices

sop for cleaning and operation of sieve shaker

general specification of packing material cartons

sop for Password for Analytical Instrument and LIMS software

sop for Rounding off numerical analytical results

sop for sampling of bulk and finished product

sop for cleaning of spillage material

sop for Handling of Reference Standard

sop for hplc column maintenance and washing

procedure for sampling and handling of bulk sample

STP for borewell generation point (raw water storage tank)

sop for preparation and standardization of 0.1M Zinc Sulphate

Operation &calibration of analytical balance (dhona)

Operation and Calibration Procedure for Disintegration Test apparatus

sop for preparation and standardization of 1 M Hydrochloric Acid

Preparation and standardization of 0.1 M ceric ammonium sulphate solution

sop for preparation and standardization of 0.05 m iodine solution

validation of volumetric solution 0.1m ammonium thiocyanate

handling of reference standard and preparation of working standard

sop for water sampling and analysis

sop for operation for validation of excel worksheets

sop for laboratory cleaning

sop for stability of volumetric solutions

sop for preparation of raw material in process finish product packing material data sheets

sop for handling of hazardous chemicals

sop for handling of glassware and allocation of identification number

sop for operation cleaning and calibration of bursting strength tester

sop for rounding off the analytical test results

procedure for Analyst Qualification

sop for operation and calibration of dissolution Apparatus

procedure for maintenance of desiccators

sop for for hplc column receipt checking id no and regeneration

safety data sheet for laboratory chemicals

procedure for handling of poisonous chemicals

sop for cleaning of sampling devices

sop for calibration procedure of instruments

sop for specification and standard testing raw material packing material and finished product

procedure for operation and calibration of potentiometric titrator

procedure for operating and calibration of digital hardness tester

procedure for disposal of expired chemicals, reagents and solvents

sop for behavior in quality control department

sop for preparation and standardization 0.1M sodium thiosulphate

sop for preparation and standardization 0.1M Disodium Edetate

preparation and standardization 0.1M Sodium Hydroxide Solution

Preparation and standardization of 0.1M Perchloric acid solution

sop for preparation 0.05M edetate disodium

sop for preparation 0.1M silver nitrate

sop for Operation and Calibration of High Performance Liquid Chromatography

sop for UV & Visible Spectrophotometer

procedure for Cleaning of laboratory glassware

Cleaning of Instrument, Instrument bench and surrounding area of Quality

Safety Precaution in Quality Control Department

Operation & Calibration of Analytical Balance

Calibration of Glassware in Quality Control Department

handling of samples received in Quality Control

Cleaning and Operation of Refrigerator

Operation, Cleaning and Calibration of water bath

Operation & Calibration of Refractometer

Operation and Cleaning of Centrifuge Apparatus

cleaning, operation & calibration of Vernier caliper

Calibration of Fourier Transform Infrared Spectrophotometer (FTIR)

Cleaning and operation of Moisture Analyzer

Cleaning & Operation of Vacuum pump in Quality Control Department

Operation cleaning and calibration of Karl Fischer Apparatus

Operation and Calibration of Polarimeter

Cleaning and operation of Magnetic Stirrer

Cleaning Operation and Calibration of Melting Point

Operation Cleaning and Calibration of Muffle Furnance in Quality Control Department

procedure of operation and Cleaning of Sonicator

Operation Cleaning & Calibration of pH meter in Quality Control Department

Entry and Exit in Quality Control Department


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