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

Editable Pharmaceutical Documents in MS-Word Format

View

8

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:





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.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


Click Here

1 comment: Post Yours! Read Comment Policy ▼


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration

Follow Pharmaguideline


CURRENT JOBS

Show All ❭❭Jobs by PharmaJobs

DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg



GET APP FOR NEWS UPDATES

Scan to Download

Android App
Android App

Recent Posts