Sampling Of Raw Materials
Department:
Quality Control
SOP No : SOP/QC/009
Objective:
To
lay down a procedure to describe the steps to be followed for sampling of all
raw materials which are received in this plant.
Scope:
Applicable to all the raw materials received in
the plant.
Responsibility:
QC
Officer: Sampling of raw material.
Accountability:
Head -
Quality Control
Procedure:
1. On
the receipt of raw materials, Warehouse will send the manufacturer COA. to QC.
2. Warehouse person must stick ‘Under test’ labels on all containers of each batch.
3. Log on in SAP, Click on “Command field” and type the Transactions code “QA33”
4. Fill the Entries in the required field (selection profile, lot creation date, plant and material – 4 series for API’s, 1 series for Excepients,
5. 9 series for retest material and 8 series for miscellaneous).
6. Select “ select only inspection lot without a usage decision” and execute or F8.
7. Double click the inspection lot number against the material and Match the Vendor batch number and material doc number by clicking on “ date for lot origin” as written in manufacturer COA.
2. Determine the number of containers to be sampled as per sampling plan.
3. Ensure that the temperature is with in the specified limit(Below 25ºC), if the temperature is more than 25°C, do not sample and inform to RM section in-charge and engineering department.
4. Check the condition, integrity and seal of individual container.
5. Reject those containers, which do not bear manufacturer’s original label.
6. Separate out damaged containers.
2. Collect the sample from the individual container for identification test into a glass vial.
3. Prepare one composite sample for complete analysis.
2. For excipients, if greater than 10 follow Ön + 1 method for sampling.
3. Prepare composite sample and perform complete analysis.
4. Damaged containers: If container is only externally damaged, but inner container is intact, take sample and perform complete analysis.
5. If container is internally damaged, reject the container.
2. Double click on the “SAP Logon” icon on the desktop.
3. Again double Click on “Log on” key and give user name and password and press “Enter” key in your Key board and SAP menu will open
4. Again Click on “Command field” and type the Transactions code “QPR4” and press “Enter” key (Confirm physical sample drawing) and Process physical sample drawing screen will be open
5. Enter Drawing number by help of the Inspection Lot Number and press ok Enter key display the inspection sample drawing number and double click on drawing number and press ok Enter key or Physical sample key and open Process physical sample drawing screen will be open.
1.Select all raw and press “Release “ or “Block” key as per requirement and give comments in “comments” field and press ok Enter key and message will be display in bottom.
2. After completion of sampling log off the SAP.
2. Switch ‘ON’ the tube lights and air curtain.
4. Switch ‘ON’ the Weighing Balance.
5. Clean the containers externally and bring the containers to be sampled (One material at a time) through material entry.
7. Use fresh pair of gloves while sampling another material.
8. Sample the material quantity as specified in “Raw material sample quantity list”.
9. For solid material, collect sample in a clean plastic bottle.Insert the sampling rod with multi compartment. Take out rod and sample from top , middle and bottom layer and make a composite sample.
10. For liquids, solvents, collect the sample in a clean glass bottle with a screw cap.Insert the liquid sample collector and take out sample from top, middle and bottom layer, make a composite sample.
11. For semi-solids and highly viscous liquids, collect the sample in a clean plastic bottle.
12. For microbial tests, collect the sample in a clean dry sterile glass bottle.
13. Take following samples separately and affix the appropriate label on the container.1. Individual sample 2. Composite sample 3.Sample for microbial testing (If applicable)4. Retain sample (Ref. SOP/QA/).
14. Label must have following details duly filled in. 1. Name of material 2. Batch No. 3. Inspection Lot No 4. Mfg. Date 5. Exp. Date 6. Signature and Date.
15. Examine each sample for physical appearance, for deterioration, in-homogeneity or other visible defect. If any sample found with any of the defect, reject the container.
16. Use sterile tools to sample the materials to be tested for microbial limit tests.
17. For solid material, collect sample in a clean plastic bottle. Insert the sampling rod with multi compartment. Take out rod and sample from top, middle and bottom layer and make a composite sample.
18. Close the glass containers with closure properly after sampling.
19. For Empty Hard gelatin capsule, collect the sample in polythene bag, for chemical analysis and for microbial testing collect in sterile well-closed container.
22. For microbial tests, collect the sample in a clean dry sterile glass bottle.
23. Use one sampling rod for one material (API’s or Excepients) and after sampling the sampling rod should be cleaned and labeled.
24. Affix the label “Sampled” on the container from which sample is withdrawn and mention the following details on the label.
25. Sign & Date:
26. Sampling details as X of Y Where, X: Sequential number of Container from which sample is withdrawn. and Y: Total number of containers to be sampled.
27. Seal the bag using nylon cable tie and wipe the container from outside with a clean dry cloth and take out from the sampling area.
28. On completion of sampling, transfer the sampling tools in the “Used tools container”.
29. Enter the details of sampling in format.
30. Clean the sampling booth as per SOP No.: SOP/QC/023 “Operation and Cleaning of reverse laminar air flow” before commencing sampling operation of other raw material, enter the cleaning type in the format.
31. Submit the samples to the QC In charge – Raw material testing and inward the details of raw material sampling into the Raw material ledger.
2. Double click on the “SAP Logon” icon on the desktop.
3. Again double Click on “Log on” key and give user name and password and press “Enter” key in your Key board and SAP menu will open.
4. Click on “Command field” and type the Transactions code “ZSAM” and press “Enter” key (SAMPLING REPORT) and Sampling report screen will be open(Attachment-II).
5. Enter all the mandatory fields like Plant, Lot creation Date, Inspection Lot No., and tick mark on “Raw material” and press key or F8 key.
6. Enter all the mandatory fields like Packed in, Condition of Containers, Storage Condition, Physical Characteristics etc.
7. Press on Execute key or F8 key and print window will be open, and type printer name in “Output Device” field and press print key and collect the sampling report.
8. On completion of sampling report log off the SAP.
2. Warehouse person must stick ‘Under test’ labels on all containers of each batch.
3. Log on in SAP, Click on “Command field” and type the Transactions code “QA33”
4. Fill the Entries in the required field (selection profile, lot creation date, plant and material – 4 series for API’s, 1 series for Excepients,
5. 9 series for retest material and 8 series for miscellaneous).
6. Select “ select only inspection lot without a usage decision” and execute or F8.
7. Double click the inspection lot number against the material and Match the Vendor batch number and material doc number by clicking on “ date for lot origin” as written in manufacturer COA.
Pre-sampling operation:
1. Verify
that the material is stored under appropriate storage condition. (Refer Raw
material storage condition list)
2. Determine the number of containers to be sampled as per sampling plan.
3. Ensure that the temperature is with in the specified limit(Below 25ºC), if the temperature is more than 25°C, do not sample and inform to RM section in-charge and engineering department.
4. Check the condition, integrity and seal of individual container.
5. Reject those containers, which do not bear manufacturer’s original label.
6. Separate out damaged containers.
Sampling plan:
1. Carry out 100% sampling of all APIs
2. Collect the sample from the individual container for identification test into a glass vial.
3. Prepare one composite sample for complete analysis.
Excipients:
1. Carry out sampling from all containers, If
number of containers is 10 or less.
2. For excipients, if greater than 10 follow Ön + 1 method for sampling.
3. Prepare composite sample and perform complete analysis.
4. Damaged containers: If container is only externally damaged, but inner container is intact, take sample and perform complete analysis.
5. If container is internally damaged, reject the container.
Procedure For Confirm Physical Sample Drawing:
1. Switch On the PC.
2. Double click on the “SAP Logon” icon on the desktop.
3. Again double Click on “Log on” key and give user name and password and press “Enter” key in your Key board and SAP menu will open
4. Again Click on “Command field” and type the Transactions code “QPR4” and press “Enter” key (Confirm physical sample drawing) and Process physical sample drawing screen will be open
5. Enter Drawing number by help of the Inspection Lot Number and press ok Enter key display the inspection sample drawing number and double click on drawing number and press ok Enter key or Physical sample key and open Process physical sample drawing screen will be open.
1.Select all raw and press “Release “ or “Block” key as per requirement and give comments in “comments” field and press ok Enter key and message will be display in bottom.
2. After completion of sampling log off the SAP.
Sample collecttion procedure:
1. Enter
the sampling area through the change room. (Refer SOP/QC/ 003 “ Entry/Exit procedure in raw material
sampling area”).
2. Switch ‘ON’ the tube lights and air curtain.
3. Switch
‘On’ the Reverse Laminar Air Flow as per Ref. No: SOP/QC/023 “Operation and
cleaning of Reverse laminar air flow”.
4. Switch ‘ON’ the Weighing Balance.
5. Clean the containers externally and bring the containers to be sampled (One material at a time) through material entry.
6. Use
all protective equipments like nose mask, hand gloves and with sleeves tucked
into the gloves while sampling.
7. Use fresh pair of gloves while sampling another material.
8. Sample the material quantity as specified in “Raw material sample quantity list”.
9. For solid material, collect sample in a clean plastic bottle.Insert the sampling rod with multi compartment. Take out rod and sample from top , middle and bottom layer and make a composite sample.
10. For liquids, solvents, collect the sample in a clean glass bottle with a screw cap.Insert the liquid sample collector and take out sample from top, middle and bottom layer, make a composite sample.
11. For semi-solids and highly viscous liquids, collect the sample in a clean plastic bottle.
12. For microbial tests, collect the sample in a clean dry sterile glass bottle.
13. Take following samples separately and affix the appropriate label on the container.1. Individual sample 2. Composite sample 3.Sample for microbial testing (If applicable)4. Retain sample (Ref. SOP/QA/).
14. Label must have following details duly filled in. 1. Name of material 2. Batch No. 3. Inspection Lot No 4. Mfg. Date 5. Exp. Date 6. Signature and Date.
15. Examine each sample for physical appearance, for deterioration, in-homogeneity or other visible defect. If any sample found with any of the defect, reject the container.
16. Use sterile tools to sample the materials to be tested for microbial limit tests.
17. For solid material, collect sample in a clean plastic bottle. Insert the sampling rod with multi compartment. Take out rod and sample from top, middle and bottom layer and make a composite sample.
18. Close the glass containers with closure properly after sampling.
19. For Empty Hard gelatin capsule, collect the sample in polythene bag, for chemical analysis and for microbial testing collect in sterile well-closed container.
20. For liquids, solvents, collect the sample in a clean
glass bottle with a screw cap.
Insert the liquid sample collector and take out
sample from top, middle and bottom layer, make a composite sample.
21. For
semi-solids and highly viscous liquids, collect the sample in a clean plastic
bottle.22. For microbial tests, collect the sample in a clean dry sterile glass bottle.
23. Use one sampling rod for one material (API’s or Excepients) and after sampling the sampling rod should be cleaned and labeled.
24. Affix the label “Sampled” on the container from which sample is withdrawn and mention the following details on the label.
25. Sign & Date:
26. Sampling details as X of Y Where, X: Sequential number of Container from which sample is withdrawn. and Y: Total number of containers to be sampled.
27. Seal the bag using nylon cable tie and wipe the container from outside with a clean dry cloth and take out from the sampling area.
28. On completion of sampling, transfer the sampling tools in the “Used tools container”.
29. Enter the details of sampling in format.
30. Clean the sampling booth as per SOP No.: SOP/QC/023 “Operation and Cleaning of reverse laminar air flow” before commencing sampling operation of other raw material, enter the cleaning type in the format.
31. Submit the samples to the QC In charge – Raw material testing and inward the details of raw material sampling into the Raw material ledger.
1. Switch On the PC.
2. Double click on the “SAP Logon” icon on the desktop.
3. Again double Click on “Log on” key and give user name and password and press “Enter” key in your Key board and SAP menu will open.
4. Click on “Command field” and type the Transactions code “ZSAM” and press “Enter” key (SAMPLING REPORT) and Sampling report screen will be open(Attachment-II).
5. Enter all the mandatory fields like Plant, Lot creation Date, Inspection Lot No., and tick mark on “Raw material” and press key or F8 key.
6. Enter all the mandatory fields like Packed in, Condition of Containers, Storage Condition, Physical Characteristics etc.
7. Press on Execute key or F8 key and print window will be open, and type printer name in “Output Device” field and press print key and collect the sampling report.
8. On completion of sampling report log off the SAP.
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