ORAL DOSAGE FORM SOPs

1.0 PURPOSE

To lay down a procedure for disposal of leftover samples after analysis 

2.0 SCOPE: 

This procedure is applicable to disposal of left over samples of raw materials, finished products, In process samples & packing materials after testing

5.0 PROCEDURE:

5.1 Leftover samples of Raw materials, in-process samples, finished products like tablets and capsules shall be collected and soaked in water prior to disposal.

5.2 The solution remains after analysis is drained by pouring in the sink and flush with sufficient water.

5.3 Toxic volatile solvents shall be drained in sink and flushed with sufficient water.

5.4 Leftover samples of Raw materials, in-process samples, finished products like tablets and capsules of penicillin group shall be collected and soaked in 0.1N Sodium Hydroxide prior to disposal.

5.5 Drain it and flush with sufficient water.

5.6 Leftover samples of printed packaging materials shall be torned and shall be shreded before putting in scrap.

5.7 Left over samples of non-printed packaging materials like vials and seals shall be de-shaped before putting in scrap.

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1.0 PURPOSE

To lay down a procedure for Rounding of Analytical results.

2.0 SCOPE: 

This procedure is applicable to in the quality control department.

5.0 PROCEDURE:

5.1 The limits are fixed numbers and hence, those shall not be "rounded off"..

5.2 The observed or calculated value shall be "rounded off" to the number of places in agreement with the limit expression by the following procedure.     

5.3  When "rounding off" of results is required, only one digit in the decimal place to the right of the  last place in the limit expression shall be considered.

5.4   if the digit is smaller than 5, it is eliminated & the preceding digit shall be decreased by one

5.5 If the digit is greater than 5, it is eliminated & the preceding digit shall be increased by one.

5.5 If the digit is 5 or more than 5, the same is eliminated and the preceding digit shall be increased  by one.

5.6 The table given below illustrates the criteria mentioned in point no.5.4 to 5.6.

5.7 No rounding shall be done in case of analytical result of related substances.

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1.0 PURPOSE

To lay down a procedure for operation and calibration of Moisture balance.

2.0 SCOPE: 

This procedure is applicable for operation and calibration of Moisture balance in the Quality control department.

5.0 PROCEDURE:

5.1 Operation procedure:

5.1.1 Make sure the equipment is clean and free from dust.

5.1.2 Put ON the mains power Supply, and press the POWER button to put ON the instrument.

5.1.3 Press the GO TO/MENU key to enter the main menu, and Press the START/STOP key to confirm.

5.1.4    Use the Down Navigation keys to move between method options, the Right navigation key to select method.

5.1.5    Use the alphanumeric keys to enter the method NAME and START/STOP key to confirm. Use Down key to select UNIT, select desired unit and press right key and confirm.

5.1.6    Use down key to select WEIGHT ASSIST and Right key to confirm. Select weight assist ON and edit Target Weight and Tolerance using the alphanumeric keys. Press the START/STOP key to confirm values and again to confirm weight assist ON.

5.1.7    Use the Down key to select Start of Analysis and Right key to save. Set Auto, Stability and Delay parameters and press the START/STOP key to confirm start analysis.

5.1.8    Use the Down key to select Heating profile and Right key to save. Select heating profile type and use the alphanumeric keys to modify temperature. Press the START/ STOP key to confirm temperature and press again to confirm heating profile.

5.1.9    Use Down key to move to Switch off Criterion and START/STOP key to confirm, then select Automatic and Press START/STOP to confirm.

5.1.10   Press the RESET/SET button to move to the pre-analysis mode and the MENU/BATCH key to load the method. Select load method and press the START/STOP key to confirm, and again to initiate drying process.

5.1.11   Open the chamber and place aluminum pan and press the TARE key. Then spread sample crystals evenly on the pan, close the chamber and press the START/STOP key to start drying.

5.1.12   Wait for analysis to be completed, then press the EXIT key to end the analysis.

5.2       Calibration:

5.2.1    Follow the Operation procedure for the moisture balance.

5.2.2    Follow paragraphs 5.1.1 to 5.1.4

5.2.3    Select DISODIUM as method name and confirm. Set unit as % Moisture and confirm.

5.2.4    Select WEIGHT ASSIST and press Right key to confirm. Select weight assist ON and edit Target weight to 5.0g and Tolerance to 10% using the alphanumeric keys. Press the START/STOP key to confirm values and again to confirm weight assist ON.

5.2.5    Select Start of Analysis and press Right key to save. And set Auto as NO, STABILITY and    DELAY as YES. Press the START/STOP key to confirm start analysis.

5.2.6    Select Heating profile and press Right key to confirm. Select STANDARD and use the alphanumeric keys to modify temperature to 110 °C then Press the START/ STOP key twice.

5.2.7  Select Switch off Criterion and press START/STOP key to confirm, then select AUTOMATIC and confirm.

5.2.8     Select Standby temperature and compile and set both to OFF. Then Press the START/STOP key to confirm.

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1.0 PURPOSE

To lay down a procedure for operation and cleaning of sampling booth.

2.0 SCOPE: 

This procedure is applicable to to operation and cleaning of sampling booths

5.0​ PROCEDURE:

5.1 Operation of RLAF in sampling booth

5.1.1 Check and ensure the cleanliness of RLAF and area.

5.1.2 Switch “ON” mains of the light of this area.

5.1.3     Switch “ON” mains of the RLAF to start the system.

5.1.4    Leave it for 5 minutes to attain the required air pressure differential.

5.1.5    Ensure that the air pressure differential of Magnehelic gauge is between defined limit and record the observation as per annexure-1.

5.1.6    If the reading is beyond the limit, immediately inform to Maintenance department for taking corrective action.

5.1.7    Start sampling of the API followed by bringing one container/bag at one time under the sampling booth RLAF area.

5.1.8    Record the sampling activity in sampling booth logbook as per Annexure-1

5.1.9    After completion of activity, switch “OFF” the RLAF.

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1.0 PURPOSE

To lay down a procedure for Preparation of Analytical reports and Certificates of Analysis.

2.0 SCOPE: 

This procedure is applicable to Preparation of Analytical reports and Certificates of Analysis for finished products, raw materials, packaging materials and in process samples in quality control.

5.0 PROCEDURE:

5.1 For In process and semi-finished sample

5.1.1 After completion of analysis chemist shall Fill the In process test report in Duplicate Received from QA as per respective specification of the products. In which one carbon copy shall be given to QA and the original copy shall be retained with QC.

5.1.2 In process testing Report shall be checked by the Officer quality control and finally approved by the head of Quality Control.

5.2       For Finished product

5.2.1 After completion of analysis chemist shall prepare the Certificates of analysis as per respective specification of the products as per Annexure-1

5.2.2 Certificates of analysis shall be checked by the Officer quality control and finally approved by the head of Quality control.

5.3 For Raw materials and Packaging materials

5.3.1 After completion of analysis chemist shall prepare the analytical test report as per respective specification of the raw materials and packaging materials as per Annexure-II.

5.3.2  Analytical test report shall be checked by the Officer quality control and finally approved by the head  of Quality control.

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1.0 PURPOSE

To lay down the procedure for the preparation of specification, standard test procedure and Raw Data sheet for raw materials, intermediates, Packing Material and finish products.

2.0 SCOPE: 

This SOP shall be applicable to Quality Control Department.

5.0 PROCEDURE

5.1 QC Department shall prepare the specifications and standard test procedures for the new products after getting intimation from QA Department.

5.2 QC Department shall prepare the specification and standard test procedure if the monograph is present in respective Pharmacopoeia.

5.3 Specification shall be prepared first and then the standard test procedure shall be prepared for the raw material and the finish product having the pharmacopeia status.

5.4  Additional tests shall be incorporated as per in-house specifications.

5.5  All the raw material specifications shall be prepared as per format given in Annexure -1.

5.6  All the raw material standard test procedures shall be prepared as per format given in Annexure -2.

5.7  All the finish product specifications shall be prepared as per format given in Annexure -3.

5.8  All the finish product standard test procedure shall be prepared as per format  given in Annexure-4.

5.9 All the general test procedures shall be prepared as per format given in Annexure-5.

5.10 All the finished product raw data sheet shall be prepared as per Annexure-6.

5.11 All the raw material raw data sheet shall be prepared as per Annexure-7.

5.12 All the Packing material Specification shall be prepared as per Annexure-8.

5.13 All the packing material standard test procedure shall be prepared as per Annexure-9.

5.14 All the packing material raw data sheet shall be prepared as per Annexure-10.

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1.0 PURPOSE

To lay down a procedure for procurement, standardization, storage and usage of reference Standard and working standard in quality control laboratory.

2.0 SCOPE: 

This procedure is applicable to procurement, standardization, storage and usage of reference standard and working standard in quality control laboratory.

5.0 PROCEDURE:

5.1 Procurement

5.1.1 Reference standards shall be procured as mentioned in individual monograph.

5.1.2 Procure the reference standard of current lot / Batch number from the relevant source. After receiving the reference standards, it shall be checked for the details on the label and COA / MSDS. Record the details in the Reference Standard Inward Record. (Annexure-1)

5.1.3 Reference standards for Non-Pharmacopoeia products which are not available with any Regulatory authority shall be procured from related manufacturer along with COA and supporting data.

5.1.4 Fresh reference standards shall be procured in case of existing reference standard shall get exhausted or if the regulatory authorities change the current Batch Number / Lot Number.

5.1.5 The earlier lot number of reference standards shall be discarded, if current lot is changed. The details of  destruction shall be entered in reference standard inward record. (Annexure-1)

5.2 Handling

5.2.1 The Usage of reference standards shall be recorded in Annexure- 2

5.2.2 Wherever reference standard is required to be dried before usage, transfer sufficient amount to a clean dry bottle, and then keep for drying.

5.2.3 Do not keep the original container in oven for drying. Do not expose a standard repeatedly at temperature above 25 ° C.

5.3 Storage

5.3.1 Store the reference standards as per the storage condition as mentioned in Label / individual Monograph.

5.3.2 All reference standards shall be stored in their original stopper containers, away from heat and protected from light.

5.3.3 If no specific storage conditions are provided in the monograph, the conditions of storage and distribution shall include protection from moisture, freezing, and excessive heat.

5.4 Procedure for standardization of working standards

5.4.1 Preparation Based on the analytical reports, select an approved lot/batch of respective raw material with high purity. Collect the required quantity of sample in a clean glass bottle and label the bottle.

5.4.2 Analyze the sample for description and identification by IR & moisture / LOD and assay in duplicate as per the procedure given in respective standard test procedure.

5.4.3 Description and Identification by IR tests should pass. The duplicate values of moisture / LOD values should be +/- 0.2% of the average value.  For assay all the values should be +/- 0.5% of the average value. If the variation is more than mentioned repeat the analysis by using fresh reagents and conditions.

5.4.4 If the assay procedure requires comparing against a standard, use reference standard of current lot.

5.4.5 Record the analytical data in “Working Standard Record of analysis –” format (Annexure-2A &2B). Calculate the Assay / Purity of working standard on as is basis.

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1.0 PURPOSE

To lay down a procedure for operation and calibration of pH meter.

2.0 SCOPE: 

This procedure is applicable to operation and calibration of pH meter in the Quality Control Department

5.0 PROCEDURE:

5.1 Operation

5.1.1 Ensure that instrument is clean and free from dust.

5.1.2 Switch ‘ON’ the mains.

5.1.3 Press power "ON/OFF" switch at the rear to "ON" position.

5.1.4 Set the temperature Compensation knob to the temperature of solution

5.1.5 Lift electrode holding clamp at the appropriate height on the rod of the electrode stand and clean the electrode with freshly prepared distilled water, wipe and dry it with tissue paper

5.1.6 Dip the electrode in the sample solution and allow sufficient time for electrode to attain temperature.

5.1.7 Press "Stand by" / "Read" Switch to "Read" and wait for 30 seconds or till stability of pH. The value of the pH sample will be displayed and note the reading.

5.1.8 The reading of pH value should be stable within 0.01 during operations, if it is not then check the sample solution is freshly prepared, electrode and instrument for proper functioning.

5.1.9 Set the selector switch to “stand by” position, rinse the electrode with freshly prepared distilled water to remove sample solution and wipe with tissue paper and dip the electrode in freshly prepared distilled water.  

5.2 Calibration:

5.2.1 pH meter is calibrated using buffer solutions of pH 4.0 (or pH 9.2) and pH 7.0

5.2.2 Operate the instrument as mention in the above procedure.

5.2.3 Prepare the buffer solutions of pH 4.0 (or pH 9.2) and pH 7.0 by dissolving 1 tablet /capsule in 100 ml volumetric in freshly prepared distilled water & make up the volume with freshly prepared purified water.

5.2.4 Place the electrode in buffer pH 7.0 solution, observe the display read out, if it is 7.0 (+0.01) then it is ok, if not then adjust the pH with the help of control knob to read 7.0 pH in the display.

5.2.5 Remove the electrode from Buffer 7.0, wash the electrode properly with freshly prepared distilled water and wipe with tissue paper and discard Buffer solution used for Calibration.

5.2.6 Place the electrode in buffer pH 4.0 solution, observe the display read out, if it is 4.0 (+0.01) then it is ok, if not then adjust the pH with the help of control knob to read 4.0 pH in the display.

5.2.7 Remove the electrode from Buffer 4.0, wash the electrode properly with freshly prepared distilled water and wipe with tissue paper and discard Buffer solution used for Calibration.

5.2.8 Place the electrode in buffer pH 9.2 solution, observe the display read out if it is in limit 9.2 (+0.01).Then it is OK.

5.2.9 Recheck buffer pH 4.0 and pH 7.0 solutions, observe the display read out, if it is in limit 4.0 (+ 0.01) and 7.0 (+0.01).

5.2.10 Tolerance limit is (± 0.01) during calibration & use buffer solutions within 7 days from date 0f preparation. Discard the buffer solution if any precipitate, turbidity or discoloration Observed during storage.

5.2.11 Calibration frequency – Daily.

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PURPOSE

To lay down a procedure for Sampling, Testing, Release and Reject of Packaging Materia

SCOPE: 

This procedure is applicable to Sampling, Testing, Release & Reject of Packaging Materials in quality control department.

5.0 PROCEDURE:

5.1 Sampling of packaging materials

5.1.1 Packaging material sampling shall be initiated after receiving the “GRN” from stores department.

5.1.2 Quality control Supervisor shall enter the material details in Packaging material inward record as per Annexure-1, and shall assign A.R. No. for each batch /lot of Packaging material.

5.1.3 Warehouse Supervisor / officer shall prepare “UNDER TEST labels as per GRN received, for each pack.

5.1.4 Quality control Supervisor shall enter in the stores dept. area along with sampling kit.

5.1.5 Sampling of foils (Aluminum, PVC & PVDC type) shall be carried out under sampling area of stores dept.  

5.1.6 Quality control Supervisor shall open each role of the Aluminum & pvc foil individually  and take out the samples as per sampling plan given below.(About one meter length) >70 gms) foil shall be drawn from each roll.)

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1.0 PURPOSE

To lay down the procedure for preparation, standardization and storage of volumetric solutions used   in routine analysis.

2.0 SCOPE: 

This procedure is applicable for preparation and standardization of volumetric Solution in the Quality Control laboratory.

2.1 To identify the strength and assay in raw material and finished product analysis.

2.2 To identify the unknown strength of volumetric solution by using known strength.

5.0 PROCEDURE:

5.1 Preparation of Volumetric solution:

5.1.1 A sufficient volume of the volumetric solutions shall be prepared as per the procedure described for preparation and standardization of volumetric solutions.

5.1.2 Use fresh ultra pure purified water.

5.1.3 Record the volumetric solution preparation as per Annexure–1. Take the signature of authorized person in the record.

5.1.4 Before signing the record, authorized person should check and ensure that solutions are prepared as per standard procedure.

5.1.5 Assign the ID No. of volumetric solution in following manner VS-XX/x/yy

        where:

      VS: Volumetric solution

XX  : Code  number 

x      : Serial No

YY   : Year

5.2       Labeling:

5.2.1    Transfer the volumetric solution from the volumetric flask to clean and dry stopper bottle.

5.2.2    Put a label with all the details as per Annexure-2

5.3       Storage of volumetric solution:

5.3.1    Store all the volumetric solution in dry and clean glass bottles. Store light sensitive solutions in amber colour glass bottles.

5.3.2    The labeled bottles of volumetric solutions shall be kept properly arranged in the racks provided for the same.

5.3.3    A sufficient volume of the volumetric solution shall be prepared to last for about one month.

5.3.4    Volumetric solution must not be preserved for more than one month.

5.3.5    If during usage any change in physical properties of the solution observed, then discard the same.

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