Pharmaceutical Guidelines

SOP for Washing of HPLC Columns Standard operating procedure to wash the columns of High Performance liquid Chromatography used in analysis of Pharmaceutical products. 1.0 OBJECTIVE To describe the procedure for washing of HPLC column. 2.0 SCOPE This SOP is applicable for washing of HPLC column. 3.0 RESPONSIBILITY Officer/ Executive - Quality Control 4.0 ACCOUNTABILITY Manager - Quality Control. 5.0 PROCEDURE 5.1 For C18, C8, C6, Phenyl, CN, Amine column: 5.1.1 Change the mobile phase to filtered distilled water. 5.1.2 Allow the water to flow through the column at the rate of 1ml / min. For 30 minutes. Check that the pressure does not exceed 400 BAR. 5.1.3 Change the mobile phase from water to HPLC grade 80% Acetonitrile. 5.1.4 Set the instrument to flow rate 1 ml/ minute and wash the column for 30 minutes. 5.1.5 Ensure that the column contains 80% Acetonitrile. 5.1.6 Disconnect the column from the HPLC unit and store in an appropriate place. 5.2 For protein pack column: 5.2.1 Change t...

SOP for Washing of HPLC Column After Use Standard operating procedure to wash the HPLC column after analysis. 1.0 OBJECTIVE To clean the column thoroughly after its each use to avoid any interference on repeated usage. 2.0 SCOPE This procedure is applicable for different groups of H.P.L.C columns used in Quality Control laboratory. 3.0 RESPONSIBILITY 2.1 Doing: Technical Assistant 2.2 Checking: Executive /Manager 4.0 ACCOUNTABILITY Head of the Department 5.0 PROCEDURE 5.1 For C18, C8, C6, Phenyl, (CN, Amine, Silica column.:) 5.1.1 Wash the column with the solvent which is use in individual product mobile phase preparation. eg. suppose water is use in mobile phase  preparation then wash the column with water. 5.1.2 Allow the minimum 30 ml washing medium to flow through the column. 5.1.3 Disconnect the column from the HPLC unit and store in an allocated place. 5.2 For Protein pack column: 5.2.1 Wash the column with minimum 30 ml of 2.5 M acetic acid. 5.2.4 Disconnect the column from ...

SOP for Verification of System Suitability Test Standard operating procedure to verify system suitability software results Vs manually of the high Performance liquid chromatography for result accuracy. 1.0 OBJECTIVE To Verify system suitability values manually v/s software. 2.0 SCOPE This procedure is applicable to verify system suitability software results Vs manually of the high-performance liquid chromatography. 3.0 RESPONSIBILITY 3.1 Doing: Technical Assistant 3.2 Checking: Executive/ Manager 4.0 ACCOUNTABILITY Head of the Department 5.0 PROCEDURE 5.1 Frequency: Once in 6 months. 5.2 Operate the instrument as per respective standard operating procedure of HPLC. 5.3 Prepare the mobile phase consisting of 70% methanol. : 30 % of water. 5.4 Prepare a mixture of 0.1 % Benzene and 0.1% Toluene in methanol. 5.5 Set flow rate at 1.0 ml/min. 5.6 Allow the system to be saturated with mobile phase for at least 15 minutes before injecting the test sample. 5.7 Record the area and retention tim...

SOP for Verification of System Suitability Test Standard operating procedure to verify system suitability software results Vs manually of the high Performance liquid chromatography for result   accuracy. 1.0 OBJECTIVE To Verify system suitability values manually v/s software. 2.0 SCOPE This procedure is applicable to verify system suitability software results Vs manually of the high-performance liquid chromatography. 3.0 RESPONSIBILITY 3.1 Doing: Technical Assistant 3.2 Checking: Executive/ Manager 4.0 ACCOUNTABILITY Head of the Department 5.0 PROCEDURE 5.1 Frequency: Once in 6 months. 5.2 Operate the instrument as per respective standard operating procedure of HPLC. 5.3 Prepare the mobile phase consisting of 70% methanol. : 30 % of water. 5.4 Prepare a mixture of 0.1 % Benzene and 0.1% Toluene in methanol. 5.5 Set flow rate at 1.0 ml/min. 5.6 Allow the system to be saturated with mobile phase for at least 15 minutes before injecting the test sample. 5....

SOP for Linearity Check of High Performance Liquid Chromatography (HPLC) Standard operating procedure to check performance of the high performance liquid chromatograph (HPLC) for accurate results. 1.0 Objective To check the performance of the equipment for reliable and accurate results. 2.0 Scope This procedure is applicable to check the performance of                                                                             the high-performance liquid chromatography. 3.0 Responsibility 3.1 Doing: Technical Assistant/Executive 3.2 Checking: Executive /Manager 4.0 Accountability Head of the Department 5.0 Procedure 5.1 Operate the instrument as per the respective standard operating procedure of HPLC. 5.4 Instrument Performance ( Linearity of Results)       Freq...

SOP for HPLC System Using Chemistation Software from Agilent Standard operating procedure of HPLC System Using Chemistation Software . 1.0 OBJECTIVE To lay down a procedure for the operation of HPLC system using Chemistation software. 2.0 SCOPE This is applicable to the operation of HPLC system using Chemistation software for Agilent HPLC system. 3.0 RESPONSIBILITY Officer/ Executive - Quality Control 4.0 ACCOUNTABILITY Manager - Quality Control 5.0 PROCEDURE 5.1 Operation of High performance Liquid Chromatograph 5.1.1 Ensure that the HPLC System is placed on a clean and dust free platform. 5.1.2 Ensure that the instrument has been connected to power supply. 5.1.3 Ensure that the all communication cords between the units are connected properly. 5.1.4 Switch on the mains and press the power switch of all modules. 5.1.5 Prepare the mobile phase as mentioned in the standard test procedure of specific                 produc...

SOP for HPLC Column Receipt, Checking and Regeneration Standard operating procedure to check the performance of the HPLC columns against the certificate received from vendor. 1.0 OBJECTIVE To lay down the procedure for checking the performance of column with respect to the certificate received from the vendor and to carry out  performance test as per in-house method. Also to describe the procedure for regeneration of column. 2.0 SCOPE This procedure is applicable to all Reverse Phase (C8, C18, cyno, phenyl) column and Normal Phase (Si) Column regeneration. 3.0 RESPONSIBILITY 3.1 Doing: Technical Assistant, Executive 3.2 Checking: Executive/Manager 4.0 ACCOUNTABILITY 4.1 Head of the Department 5.0 PROCEDURE 5.1 Checking of new HPLC column 5.1.1 On receipt of a new column from the vendor, condition the column using methanol at             0.5 ml/min. 5.1.2 Check the column with respect to the certificate of analysis for back press...