Pharmaceutical Guidelines

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...