Good Laboratory Practices (GLP) Part-1

✔ Technical Review by: Dr. Ankur Choudhary, Ph.D. Ø Use / follow correct specifications, methods of analysis and SOPs at the time of work. Ø Only trained persons should perform the activity. 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. 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. 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 MedicGLP Weight Management once the balance is stabilized.

Ø Follow the SOP correctly. Ø Do not forget to check cleanliness before & after weighing. 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 MedicGLP 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. 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. 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 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.

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