Good Laboratory Practices (GLP) Part-1 : Pharmaceutical Guidelines

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Good Laboratory Practices (GLP) Part-1

GLP about Methods, Personnel, Instruments/Equipment, Dilutions, Weighing, Mobile phase preparation, HPLC and Column care


Ø  Use / follow correct specifications, methods of analysis and SOPs at the time of work.


Ø  Only trained persons should perform the activity.


Ø  Qualified & calibrated instruments / Equipment to be used.
Ø  While working in the laboratory, ensure that all the required PPE’s & RPE’s are used.
Ø  Ensure that the instruments are in calibrated status.
Ø  After completion of analysis if the instrument is not in use, then ensure that all switches are turned off.
Ø  All the distillation and reflux operations should be performed in the hood and the analyst should attend to the experiment.
Ø  Clean the working table, instruments before & after completion of analysis.
Ø  Keep the laboratory notebook, column and chemicals at designated places after / when not in use.
Ø  After opening a chemical bottle, write down the opened on the date and use before date on the label of the bottle.
Ø  Take all necessary precautions while handling Hazardous/poisonous chemicals.
Ø  Follow proper garment policy while entering the microbiology laboratory.
Ø  Do not enter in the areas which are restricted for entrance.
Ø  Do not bring any food/ medicines to the laboratory.

Related: SOP for Careful Handling of Poisonous Chemicals


Ø  Use appropriate, cleaned & dried volumetric apparatus.
Ø  Label the glassware, which is in use.
Ø  Ensure that the pipettes and volumetric flasks are of Class A grade.
Ø  Ensure that the tip of pipettes is proper and not broken.
Ø  Use appropriate solvents for dilution.
Ø  Wipe the pipette before inserting into the volumetric flask.
Ø  Make the dilutions carefully & accurately.
Ø  Do not use contaminated sucker/rubber bulb.
Ø  Make up the volume of the solution when it is at room temperature.
Ø  Follow the methods properly & crosscheck once.

Related: Calibration of Volumetric Glassware


Ø  Ensure that the balances are clean and calibrated.
Ø  Check the spirit level of the balance before use.
Ø  Balance weighing range & capacity should be considered before weighing.
Ø  Take the weight once the balance is stabilized.
Ø  During weighing the door of the balance & balance room should be closed properly
Ø  Follow the SOP correctly.
Ø  Avoid spillage.
Ø  Do not forget to check cleanliness before & after weighing.

Related: Analytical Balance Calibration

   Mobile phase preparation:

Ø  Use appropriate solutes & solvents as per the specified procedure.
Ø  The solvents should be degassed before use.
Ø  Weigh as accurate as possible.
Ø  Make pH adjustments on calibrated pH meter & always within the tolerance given in the method.
Ø  The pH meter should be calibrated for upper and lower buffer pH range.
Ø  Do not forget to clean the pH meter electrode with plenty of water before and after use.
Ø  Make appropriate entries of the pH calibration and buffer in the pH meter log.
Ø  Take appropriate measuring cylinder for mobile phase preparation.
Ø  Filter & degas before use.
Ø  Prepare sufficient mobile phase required for analysis. Do not mix two lots of mobile phase.

Related: Guideline for Preparation of Mobile Phase

   Column care:

Ø  Avoid any jerks or vibrations to the column.
Ø  Always replace the column ferrules whenever the column is to be kept idle & fix end caps to avoid silica drying.
Ø  Store the column in appropriate solvents suggested by manufacturer.
Ø  Wherever specified, use proper guard columns.
Ø  Use the column for particular Raw material/ product/ test whenever required.
Ø  Before and after analysis wash the column with prescribed solvent.
Ø  Use/ Attach the column in the same direction of flow provided by the manufacturer.

Related: HPLC Column Performance Evaluation and Column Care


Ø  Flush the complete system (without column) with warm water (40°) once in a week using a union instead of a column.
Ø  If the system suitability is not achieved by the column then regenerate the column as per manufacturer’s instructions / SOP for column generation.
Ø  Purge seal wash line, injector and all the inlets of the pump with water before use.
Ø  Sonicate all ports inlet filter with [water: methanol (50:50)] once in a week.
Ø  Check the tubing/Syringe for air bubbles of all ports.
Ø  Check the valves for precipitation & clogging.
Ø  Clean all the inline filters, frits & check valve cartridges at least twice in a month.
Ø  Before converting the system to normal phase wash with water/ Methanol/ IPA/ Diluent serially.
Ø  After completion of the analysis, follow the reverse procedure to convert to reverse phase.
Ø  Do not store system in solvents.
Ø  For purging of system start with the lower flow and then stabilize system at the required condition.
Ø  After analysis take backup of the data in the relevant location.
Ø  Ensure that the system is calibrated before use.
Ø  Before the start, ensure that respective solvents & inlets inserted are as per the requirements.
Ø  After analysis, do not leave the system idle in harsh solvents like ACN, store the system in ACN: Water mixture (20:80).
Ø  Avoid spillage on the system.
Ø  Do not interchange any of the modules or parts among the systems even of the same make. 

Related: HPLC Calibration in Pharmaceuticals

Also see:

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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