Good Laboratory Practices (GLP)
GLP about Methods, Personnel, Instruments/Equipment,
Dilutions, Weighing, Mobile phase preparation, HPLC and Column care
• Methods
Use / follow correct specifications, methods of analysis and
SOPs at the time of work.
• Personnel
Only trained persons should perform the activity.
• Instruments/Equipments
Qualified & calibrated instruments / Equipments to be
used.
While working in laboratory, ensure that all the required
PPE’s & RPE’s are used.
Ensure that the instruments are in calibrated status.
After completion of analysis if the instrument is not in use, then ensure that all switches are turned off.
After completion of analysis if the instrument is not in use, then ensure that all switches are turned off.
All the distillation and reflux operations should be
performed in hood and the analyst should attend to the experiment.
Clean the working table, instruments before & after
completion of analysis.
Keep the laboratory notebook, column and chemicals at
designated places after / when not in use.
After opening chemical bottle, write down the opened on date
and use before date on the label of the bottle.
Take all necessary precautions while handling
Hazardous/poisonous chemicals.
Follow proper garment policy while entering in the
microbiology laboratory.
Do not enter in the areas which are restricted for entrance.
Dilutions:
Use appropriate, cleaned & dried volumetric apparatus.
Label the glassware, which is in use.
Ensure that the pipettes and volumetric flasks are of Class A
grade.
Ensure that the tip of pipettes is proper and not broken.
Use appropriate solvents for dilution.
Wipe the pipette before inserting in the volumetric flask.
Make the dilutions carefully & accurately.
Do not use contaminated sucker / rubber bulb.
Make up the volume of the solution when it is at room
temperature.
• Weighing:
Ensure that the balances are clean and calibrated.
Check the spirit level of the balance before use.
Balance weighing range & capacity should be considered
before weighing.
Take the weight once the balance is stabilized.
During weighing the door of the balance & balance room should
be closed properly
Follow the SOP correctly.
Avoid spillage.
• Mobile phase preparation:
Use appropriate solutes & solvents as per the specified
procedure.
The solvents should be degassed before use.
Weigh as accurate as possible.
Make pH adjustments on calibrated pH meter & always
within the tolerance given in the method.
The pH meter should be calibrated for upper and lower buffer
pH range.
Do not forget to clean the pH meter electrode with plenty of
water before and after use.
Make appropriate entries of the pH calibration and buffer in
the pH meter log.
Take appropriate measuring cylinder for mobile phase
preparation.
Filter & degas before use.
• Column care:
Avoid any jerks or vibrations to the column.
Always replace the column ferrules whenever column is to be
kept idle & fix end caps to avoid silica drying.
Store the column in appropriate solvents suggested by
manufacturer.
Wherever specified, use proper guard columns.
Use the column for particular Raw material/ product/ test
whenever required.
Before and after analysis wash the column with prescribed
solvent.
Use/ Attach
the column in same direction of flow provided by manufacturer.
• HPLC
Flush the complete system (without column) with warm water
(40°) once in a week using union instead of column.
If the system suitability is not achieved by the column then
regenerate the column as per manufacturer’s instructions / SOP for column
generation.
Purge seal wash line, injector and all the inlets of pump
with water before use.
Sonicate all ports inlet filter with [water: methanol
(50:50)] once in a week.
Check the tubing/Syringe for air bubbles of all ports.
Check the valves for precipitation & clogging.
Clean all the inline filters, frits & check valve cartridges
at least twice in a month.
Before converting the system to normal phase wash with water/
Methanol/ IPA/ Diluent serially.
After completion of analysis, follow reverse procedure to
convert to reverse phase.
Do not store system in solvents.
For purging of system start with lower flow and then stabilize system at required condition.
After analysis take backup of the data in the relevant location.
Do not store system in solvents.
For purging of system start with lower flow and then stabilize system at required condition.
After analysis take backup of the data in the relevant location.
Ensure that the system is calibrated before use.
Before start, ensure that respective solvents & inlets
inserted are as per the requirements.
After analysis, do not leave the system idle in harsh
solvents like ACN, store the system in ACN : Water mixture (20:80).
Avoid spillage on the system.
Do not interchange any of the modules or parts among the
systems even of the same make.
