Good Laboratory Practices (GLP) Part-1

•   Methods

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

•   Personnel

Ø  Only trained persons should perform the activity.

•   Instruments/Equipments

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

•   Dilutions:

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

•   Weighing:

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

•   HPLC

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:

• Good Laboratory Practices (GLP) Part-2
• Good Laboratory Practices (GLP) Part-3