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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
• 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

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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