GOOD LABORATORY PRACTICES

1. OBJECTIVE:

To lay down a procedure for ensure the good Laboratory practices.

• SCOPE:

This procedure is applicable for procedure for ensure the good laboratories practices.

• RESPONSIBILITY:

QC Officer/ QC Executive

• ACCOUNTABILITY:

QC Manager.

•  PROCEDURE:
  • Good Laboratory Practices (GLP)
    • Prepare the Standard Operating Procedures, for the Quality Control Laboratory.
    • Establish the specifications for Raw Materials, Packing Materials and Finished products and their periodical review.
    • Establish the method of analysis for Raw Materials, Packing Materials, intermediates and finished products.
    • Carry out and monitor the stability studies of products as per ICH guidelines.
    • Check all activities as per Standard Operating Procedures.
    • Get trained to QC chemists for handling of chemicals, glassware’s and instruments and for the laboratory analytical work by chemical instrumental and microbiological methods of analysis.
    • Get trained to analyst for maintaining use logs of instruments, records of analysis such as raw data in laboratory protocols, with supporting printouts and graphs etc. of instrumental analysis, and the Certificate of Analysis.
    • Implementation of cGMP and cGLP, by laboratory personnel.
    • Validation of analytical methods and records.
    • Setting up a system of quality assurance through Self-inspections.
    • Use of calibrated instruments only.
    • Follow laboratory discipline.
    • Use standardized volumetric solutions and reagents.
    • Every sample must be tested, as per its respective method of analysis, in exactly the same way.
    • Working area must be clean and tidy.
    • All market complaints are investigated and follow-up action is taken to rectify/ overcome complaints, prevent reoccurrence, if any.
    • Records must contain details of product recall, if any.
    • All testing procedures are reviewed and kept up to date.
    • Records must be complete and accurate.
    • All data acquired during analysis are recorded immediately and accurately.
    • Follow Laboratory safety guideline and observe safe practices.
  • Laboratory Safety:
    • Select the area for routine laboratory work and use.
    • Fuming chamber for handling hazardous chemicals like acids fuming chemicals etc.
    • Check the apparatus for leakage before commencing heating.  Avoid heating on direct flame.
    • In the separating funnel, release the pressure developed on shaking by inverting the funnel with the stopper securely held and opening the stop cock with care.  Point the funnel away from the eyes, any flame or heating mantles.
    • Inflammable substances should be heated on water bath or electrically heated bath.
    • Ensure that the size of the reaction flask is adequate enough for possible frothing.
    • Never start experiment on a bench already crowded with apparatus.
    • Avoid leaving a laboratory experiment unattended.
    • Never remove the guards or safety devices from a machine.
    • Use lubricant and a cloth for protection while inserting glass tubing, rods or thermometer in to bungs or tubing.
    • Take care in handling glass capillaries.
    • Laboratory store rooms and refrigerators should be inspected regularly.
    • Do not store flammable solvents in the refrigerator.  Do not store food items in the refrigerator.
    • Ensure that special precautions are being observed when work on pathogenic microorganism is carried out in the laboratory.
    • Keep all chemicals in lock and key and maintain stock register.
    • Fire extinguisher should be at proper place and within reach.
• TRAINING:

Trainer   :  Manager – Quality Control

Trainees:  Staff of the QC departments

• DISTRIBUTION:

Master Copy                  :            QA Department

Controlled Copy            :           QC Department

Display Copy                 :           QC Department (If Required)

• REFERENCES:

In-House