Good Laboratory Practices (GLP) - Part 1

  • 22, 07, 2021

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

1. Methods

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

2. Personnel

Ø Only trained persons should perform the activity.

3. 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 date and use before date on the bottle's label.

Ø Take all necessary precautions while handling Hazardous/poisonous chemicals.

Ø Follow proper garment policy while entering the microbiology laboratory.

Ø Do not enter the areas which are restricted for entrance.

Ø Do not bring any food/ medicines to the laboratory

4. 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 it into the volumetric flask.

Ø Make the dilutions carefully & accurately. Ø Do not use contaminated sucker/rubber bulbs.

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

5. 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 balance & balance room door 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

6. Mobile phase preparation

Ø Use appropriate solutes & solvents as per the specified procedure.

Ø The solvents should be degassed before use.

Ø Weigh as accurately 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. 

7. 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.

8. HPLC

Ø Flush the complete system (without column) with warm water (40°) once a week using a union instead of a column.

Ø If the column's system suitability is not achieved by the column, then regenerate the column as per the 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 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 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 the 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.

Source: Pharmaguideline

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