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SOP OF Good Laboratory Practice

This document outlines standard operating procedures for Good Laboratory Practice in a Quality Control laboratory. It details responsibilities and accountability, laboratory premises requirements including ventilation and cleanliness, equipment use and calibration, documentation practices, chemical and reagent handling, staff training, safety protocols, housekeeping, and revision history. The goal is to lay down standards to ensure quality testing and compliance with Good Laboratory Practice.

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2K views

SOP OF Good Laboratory Practice

This document outlines standard operating procedures for Good Laboratory Practice in a Quality Control laboratory. It details responsibilities and accountability, laboratory premises requirements including ventilation and cleanliness, equipment use and calibration, documentation practices, chemical and reagent handling, staff training, safety protocols, housekeeping, and revision history. The goal is to lay down standards to ensure quality testing and compliance with Good Laboratory Practice.

Uploaded by

Yousif
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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SOP of Good Laboratory Practice

 OBJECTIVE

To lay down a standard procedure for implementation of Good Laboratory


Practices (GLP) in the Quality Control Laboratory.

 SCOPE

This SOP is applicable to Quality Control Laboratory at

 RESPONSIBILITY

o Officers / Executive – Quality Control shall be responsible for


complies of this SOP
o ACCOUNTABILITY
o Manager- Quality Control and Head QA shall be accountable for
compliance of this SOP.

5.0    ATTACHMENTS

Nil

6.0    PROCEDURE

 GOWNING AND WORK HABITS:

6.1.1 All Department employees shall wear a Laboratory apron and shoes /
slippers in the laboratory.

6.1.2 Analysts shall work at the respective workplace and keep them neat and
clean (including table and drawers).
6.1.3 Analyst shall wear safety glasses, nose masks and hand gloves, whenever
required during the testing.

 QULITY CONTROL LABORATORY PREMISE:

o Quality Control Laboratory function shall be free from dust and


other disturbances. Mopping of the floor shall be done twice daily.
o The premise of Quality Control department shall be well
ventilated, with proper arrangements of air conditioning. Microbiological areas
have independent AHUs to avoid contamination.
o The laboratory plan including its furniture shall be constructed in
such a way to facilitate smooth working.
o Working tables shall be smooth and resistant to most of the acids,
alkalis and solvents and easily cleanable. Floor and ceilings shall also be easily
cleanable.
 INSTRUMENTS:
o Wherever required, instruments shall be kept in controlled
temperature and humidity, as per manufacturer recommendations.
o All instruments shall be kept clean every time and serviced
regularly as per the Annual Maintenance Contracts and/or paid service plan with
the outside agencies or from the In-house resources.
o A record of the service performed on each instrument shall be
maintained.
o Instruments shall be calibrated and / or validated as per applicable
SOPs. Record of calibration and / or validation shall be maintained.
o Standard operating procedure for each instrument shall be made
available separately for its operation and cleaning, calibration.
o All the instruments shall be switched off after use, unless
required.
 GLASSWARE:
o All the glassware shall be procured from standard glassware
manufacturers.
o Glassware used for quantitative purposes shall be of ‘A’ Grade or
Calibrated ‘B’ Grade.
o ‘A’Grade glassware shall be used after reviewing the
manufacturer’s certificate, if and only if the certificate is matching the acceptance
limit.
o ‘B’ Grade glassware shall be used after the In-house calibration.
o Glassware shall be cleaned properly as per SOP No. SOP/QC-007
after each analysis, and dried before next use. The analyst shall verify the
cleanliness of the glassware by visually inspection, before use.
o After completion of analysis, glassware containing hazardous
chemicals and poisonous materials shall be emptied immediately into the sink
under continuous flow of water, and then shall be kept in the washing trays.
 DOCUMENTAION:
o Current departmental SOPs shall be strictly followed by all
employees in the laboratory.
o Properly authorized specifications, Standard test procedure and
other required work instructions shall be available in Quality control laboratory
for each analysis for each product.
o All the materials shall be analyzed strictly as per the respective
current specifications.
o Recording of primary data shall be done in approved test data
sheet formats only.
o No change in document shall be allowed unless a written
authorization through proper change control procedure is being followed.
o After analysis test data sheet along with supporting raw data,
documents, graphs, printouts, samples, report etc. shall be submitted to Head
Quality control. It shall be checked, verified and stored along with the respective
document file.
 CHEMICALS AND REAGENTS:
o All the chemicals shall be stored as per their properties and
hazardous nature viz. inflammable, at the designated place.
o All the chemicals and reagents shall be labeled properly on
receipt. Labels on chemicals and reagents shall bear the standard labels.
o All chemicals / reference standards / working standards shall be
kept back to their respective designated place after use and should be sealed
properly.
o Chemicals and reagents shall not be pipette through mouth.
Rubber bulbs shall be used for this purpose.
o Chemicals and reagents taken out for analysis shall not be
returned back to the mother container. This shall be discarded.
o Hazardous solutions shall be handled with precaution at the
designated area.
o No storage of any solutions (except stock solution with proper
labels) in refrigerator or in cupboards shall be done.
 PERSONAL TRAINING:
o Laboratory staff shall be adequately qualified and sufficient in
number to perform the assigned analytical work.
o All the personnel shall undergo on-the job training in all Quality
Control and Quality Assurance functions.
o Each new recruit shall undergo induction training and training
related to the different analysis areas.
 SAFETY:
o An Officer / Executive shall be identified as Safety Officer. The
Safety practices followed in the laboratory shall be monitored by the Safety
Officer.
o Proper hand gloves, goggles and nose masks shall be used during
handling of volatile corrosive chemicals.
o First aid box shall be available in the chemical testing room.
Necessary first aid facility shall be available in laboratory, with instant access.
o All the electrical lines and gas lines shall be switched off after
use.
o Proper safety precautions, wherever specified, shall be followed
during analysis.
o Fire extinguishers and water showers shall be installed /kept for
safety purpose.
 HOUSEKEEPING:
o Laboratory shall be neat and clean. The record of its cleaning shall
be maintained as per SOP in Quality Control Department.
o Instruments, working tables and drawers shall be kept clean by the
analyst.
 MISCELLANEOUS:
o Results of out of specifications (OOS) shall be immediately
reported to Head Quality Control in case of any discrepancy sops of OOS shall be
followed.
 REFERENCES
   In-house

 ABBREVIATIONS

   SOP: Standard Operating Procedure.

OOS: Out of Specification

QA: Quality Assurance

QC: Quality Control

AHUs: Air Handling Units

 DISTRIBUTION LIST

   Quality Assurance Department

Quality Control Department

10.0  HISTORY OF REVISION

Version No. Date of Revision Reason for Revision

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