ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To lay down a procedure for operation and calibration of bursting strength apparatus.

2.0 SCOPE: 

This procedure is applicable to operation and calibration of bursting strength apparatus in Quality control department

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To lay down a procedure for operating and calibration of Scuff Resistance tester.

2.0 SCOPE: 

This SOP is applicable for Scuff Resistance tester used at Quality Control laboratory.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To provide a procedure for handling of chromatographic columns.

2.0 SCOPE: 

This SOP is applicable to receipt, evaluation, usage, conditioning and destruction of columns received and maintained at quality control laboratory.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To lay down a procedure for Operation and Calibration of Tap density apparatus.

2.0 SCOPE: 

This procedure is applicable for operation and calibration of Tap density apparatus used in Quality Control laboratory

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To lay down procedure for Operation and calibration of Tablet hardness tester.

2.0 SCOPE: 

This procedure is applicable to the Tablet Hardness tester used in Quality Control laboratory.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download

1.0 PURPOSE

To lay down a procedure for operation of the potentiometric titrator.

2.0 SCOPE: 

Procedure is applicable for operation of the potentiometric titrator in the Quality control department

5.0 PROCEDURE:

5.1 Operation

5.1.1 Ensure the controls are kept thus before switching ON the instrument. Put the SELECTOR   switch to ‘O’, STIRRER switch to ‘MIN’,  SET POINTER COARSE and  FINE to about middle of its full range and the tips of the sensors above the level of solution in the beaker

5.1.2 Connect the main supply and switch ON the mains. The display will show a value near zero.

5.1.3 Rotate the stirrer control knob and adjust the stirrer speed.

5.1.4 Connect the pins of the sensors to the sockets on the machine on both sides of the support rod( calomel to black socket) and lower the tips of the sensors with the spring clamp so that the tips of the sensors are well immersed   in the solution in the beaker.

5.1.5 Turn the SELECTOR to the ‘POT-G’ if the Glass/Calomel pair is used or ‘POT-M’ if Metal/Calomel pair is used.

5.1.6 Use the SET POINTER to adjust the display to near point ‘0’.The FINE SET POINTER is used to adjust the milli volts reading precisely to ‘0’ while the COARSE control is used for major millivolt reading.

5.1.7 Add some drops of solution from the burette and note the reading on the digital display. Add fixed volume of the solution from the burette (1ml, 0.5ml, and 0.1ml), every time and note the change in milli volts for each addition. For the same addition every time the display will show larger and larger change in the milli volts and at the END POINT the change will be suddenly large. With additions the change will be progressively smaller and smaller. The burette reading corresponding to the maximum change in milli volts should be considered for calculations.

5.1.8 Use the COARSE and FINE set pointer to adjust the display to ‘0’ when the selector is on ‘POT-G’ and only the COARSE set pointer when the selector is on ‘POT-M’.

5.1.9 Procedure for using the instrument with glass/calomel sensors for non-aqueous titrations.

5.1.10 Keep the selector switch to ‘0’ position.

5.1.11 Fit the Glass and Calomel sensors in the clamp carefully. Attach the lead of the calomel sensor to the black terminal and the lead of the glass sensor to the special BNC connector fitted at the rear plate of the instrument.

5.1.12 Take about 60ml Glacial acetic acid in the beaker and lower the sensors. Fill the right hand side burette with 0.1N perchloric acid. For efficient observation the normality of the solution in the burette should be greater than that in the beaker.

5.1.13 Start the magnetic stirrer and adjusts its speed suitably. Turn the SELECTOR to the ’POT-G’ and adjust the display near about 0mv.

5.1.14 To neutralize the acetic acid add 0.1ml perchloric acid from the burette. The display will show large change in milli volts. (More than 50 to 80 mv).

5.1.15 Add the sample in the beaker and dissolve it completely. (If necessary the solution may be heated to dissolve the sample completely).

5.1.16 Keep adding a fixed volume of solution from the burette (0.5 ml, 0.1ml depending on the strength) and note the change in mili volts. Maximum change in milli volt will be observed at the ‘END POINT’. If the mv reading is beyond 250 to 300 mv adjust the display near the 0 mv by using the FINE and COARSE set pointer control.

5.1.17 Draw a graph of change in millivolts v/s volume added. The peak of the graph indicates the END POINT.

5.1.18 Keep the SELECTOR switch to point ‘0’ while changing the solution or electrodes.

5.1.19 Procedure for using instrument with metal /calomel sensors for aqueous titrations.

5.1.20 Keep the sensor to ‘POT-M’

5.1.21 Use the platinum sensor and connect it into the Red socket.

5.1.22 Follow the procedure as from 5.2.3.

5.1.23 Clean the tip of the Platinum sensor with smooth emery paper after few titrations.

5.1.24 Procedure for oxidation/ reduction titrations

5.1.25 Connect the Calomel sensor in the Red socket and the Metal sensor in the Black socket. The calomel/Pt-sensors is preferred but the Pt/Pt pair can be used but should be perfectly clean without scratches.

5.1.26 Keep the controls in the same way as for potentiometric titrations till 5.1.3

5.1.27 Lower the sensors in the beaker and dip tips in the solution of 0.1N sodium-thio-sulphate.

5.1.28 Turn the SELECTOR to ‘O-R’ position. The set pointer control will now have no effect on the digital display.   Display shows a positive value near 250mv.

5.1.29 Add 0.1N iodine solution from the burette (0.1ml) every time. At the END POINT the digital display will show a sudden large deflection from positive to negative.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download         

1.0 PURPOSE

To lay down the procedure for Calibration Procedure of Gas Chromatograph

2.0 SCOPE: 

This procedure is applicable to the Gas Chromatograph used in Quality Control laboratory. Make/Model: - Agilent, Model – 7890B with Head Space Model – 7697A.

5.0 PROCEDURE:

5.1 Installing Capillary column in capillary inlets:

5.1.1 Install column nut and ferrule on the column. Graphite ferrule to be select depending upon the column outer diameter.

5.1.2 Make both the column ends flat using cutter if required.

5. 1.3 Insert column in Nut and ferrule approximately 1-2 mm for inlet & 5-6 mm for FID (including) back of the nut.

5.1.4 Insert column ferrule and nut straight into the inlet base, Tighten the nut to finger-tight, or using a wrench.

5.2 Operating procedure

5.2.1 Make the usage entry of every activity on gas chromatograph in the instrument usage log book.

5.2.2 Switch on the Gas Chromatograph and Headspace Sampler (for GC-HS).

5.2.3 Open the carrier gas Regulator valve or GC key panel.

5.2.4 Replace injector septa and liner if required.

5.2.5 Connect the column to the injector side while keeping the other end open and purge Nitrogen for few seconds.

5.2.6 Confirm the carrier gas flow from other end by dipping it in Methanol / IPA and water mixture, bubbles must form at the outlet.

5.2.7 Insert the other end of the column to the detector side and ensure tightness at both ends using spanner or suitable tools.

5.2.8 Check leakage from both the ends using 1:1 mixture of Methanol / IPA and water (If required) and after ensure shut the door.

5.2.9 Optimum flow ratio of Zero Air and Hydrogen shall be 10:1 (i.e. – 400:40) until /unless not given in the STP.

5.2.10 Display signal by pressing the GC key panel.

5.2.11 Switch on the computer. After confirming that all the units were switch on, turn the PC power ON, Computer monitor will display the Cp Control Panel.

5.2.12 Create the instrument method and sequence as per Standard Operating Procedure for Operation of Gas Chromatograph and follow the following steps for the calibration.

5.3 Calibration:

5.3.1 Flow Calibration (For Capillary Column)

5.3.2 Install the column.

5.3.3 Set the flow at 1.0 mL/min and check the flow at FID maintaining hydrogen, zero air and make up flow at zero. Now check the flow at FID using digital flow meter.

5.3.4 Set the flow at 2.0 mL/min and check the flow at FID maintaining hydrogen, zero air and make up flow at zero. Now check the flow at FID using digital flow meter.

5.3.5 Set the flow at 5.0 mL/min and check the flow at FID maintaining hydrogen, zero air and observing flow at zero. Now check the flow using digital flow meter.

5.3.6 Set the flow at 10.0 mL/min and check the flow at FID maintaining hydrogen, zero air and observing flow at zero. Now check the flow using digital flow meter.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download         

1.0 PURPOSE

To lay down a procedure for the operation of the laboratory Oven

2.0 SCOPE: 

This procedure will be applicable for the operation of Laboratory Oven in the quality control department.

5.0 PROCEDURE:

5.1 Put ‘ON’ the mains supply

5.2 Press the ‘2’ Button to set the temperature controller, simultaneously pressing the ‘3’ or ‘4’buttons until the desired set temperature is displayed

5.3 After increase or decrease Press the ‘1’ button and the actual temperature will be displayed. The Unit ensures the new set temperature is attained after 5 to 10 minutes.

5.4 Place the samples in the oven and close firmly.

5.5 When the heating time is Elapsed, put off the Mains and remove samples from the oven.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download         

1.0 PURPOSE

To lay down procedure for Operation and Calibration of Disintegration test apparatus.

2.0 SCOPE: 

This procedure is applicable to the Disintegration test apparatus used in Quality Control department.

5.0 PROCEDURE:

5.1 Operating Procedure:

5.1.1 Ensure the instrument is clean.

5.1.2 Fill the tank with Distilled Water up to the water level mark.

5.1.3 Switch ‘ON’ the Main supply on the instrument ‘ON/OFF’ switch key on the rear side.

5.1.4 Switch ‘ON’ the heater by pressing Heater switch at the rear end of apparatus.

5.1.5 Press the Enter key.

5.1.6 Enter the temperature of test as 37°C, and press the Enter key. Display shows heating in progress.

5.1.7 Press start menu key, from the display select “test”

5.1.8 Enter product settings.

5.1.9 Enter the batch number, and press the Enter key, Display shows “beaker warming up”, and later “Insert tablets”

5.1.10 The display show inserts the sample.

5.1.11 Place one tablet / capsule to be tested in each of the six cylinders of basket rack assembly.

5.1.12 Place the disks and Press ‘Start/Menu’ key once to start the test.

5.1.13 Watch the complete disintegration of the tablet / capsule and note down the time.

5.1.14 Press ‘Start/Stop’ key to stop the test.

5.1.15 Record the details in the Disintegration test apparatus logbook.

5.2 Calibration Procedure:

5.2.1 Calibration of Temperature

5.2.1.1 Ensure that the beakers are filled with the distilled water

5.2.1.2 Switch ‘ON’ the main supply and switch ON the instrument ‘ON/OFF’ key on the rear side of the instrument

5.2.1.3 Switch “ON” the heater and confirm that the temperature of water is 37°C, when the display shows the temperature 37°C. Keep ready a calibrated thermometer.

For Complete SOP with Annexures - Click on Read more, Subscribe and Download   

1.0 PURPOSE

To lay down the procedure for operation of High-performance liquid chromatography

2.0 SCOPE: 

This procedure is applicable to the High-performance liquid chromatography system used in Quality Control department.

5.0 PROCEDURE:

5.1 Operating procedure:

5.1.1 Power On the main switches of all the modules.

5.1.2 Power ON the switches located on front panel of all the modules.

5.1.3 Check that all modules are initialized and ready.

5.1.4 Purge the required ports to remove air bubbles from inlet tubes.

5.1.5 Double Click and open ChromNAV Software.

5.1.6 Login with Username and Password

5.1.7 Select the required Project and Open it.

5.2 Method

5.2.1 Go to File Menu – Method Editor- Control Method- Click on Import Configuration

5.2.2 Then set required Method Time.

5.2.3 Then Click on PUMP and set required parameters.

5.2.4 Then set Column Oven Parameters

5.2.5 Then UV Detector Parameters.

5.2.6 No need to change parameters in CTRL Tab, Just save the Control Method, give required name

Calibration of pump:

Calibration of wavelength:

Calibration of detector:

For Complete SOP with Annexures - Click on Read more, Subscribe and Download