SOP:Sampling and inspection of raw material.

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SOP:Sampling and inspection of raw material.

 

PRECAUTION:

  1. Solid & Liquid Raw material sampling to be done in sampling booth.
  2. In case of hygroscopic material close the container immediately after use.
  3. If material is light sensitive then cover the tube by amber coloured film and then sampling is to be done of that material.
  4. If the material is light sensitive, use black bag to cover the primary bag.

PROCEDURE:

 For Solid Raw Materials

  1. Receive GRN through ERP from store department.
  2. One should take the entry in QC register through ERP and print the “UNDER TEST” Labels on yellow coloured papers.
  3. Then go to store for sampling by following procedure with “under test and sampled label”
  4. Sampling to be done in sampling Booth.
  5. Exit the QC laboratory through change room following proper exit procedure.
  6. Enter in stores department area according to given procedure.
  7. Check the details of the container against GRN.
  8. Verify label from containers for Name of Material, Batch No., Mfg. Date, and Exp. Date etc as per GRN.
  9. Fill the check list for checking the consignment before sampling (Annexure I).
  10. If the Material is Active Raw Material 100% sampling to be done, withdraw the sample from each & every container for Identification test.
  11. If Material is Inactive Raw Material select container as per the formula √n + 1, where n is a total number of containers.
  12. If the consignment is received from new supplier and or from Non approved vendor withdraw the sample from each and every drum, for Identification.
  13. If any damaged or exposed container is found in consignment at the time of sampling, treat that drum or container as separate for sampling & analysis.
  14. Ensure that sampling Booth area should be neat and clean.
  15. Switch ‘ON’ AHU of sampling area, blower and light of sampling Booth unit.
  16. Ensure that pressure of magnahelic gauge should be between 8 to 18 mm Wg column. Wait for stabilization of sampling Booth. If magnahelic gauge not in between then inform to store department and QA to take corrective action.
  17. During sampling wear over gown, hand gloves, nose mask.
  18. Transfer the selected containers of consignment near sampling booth via pass box.
  19. Open the Container/Drum/bag in sampling booth for sampling.
  20. Check for physical appearance, if physical appearance is found within specification, then withdraw the sample from all container/s or selected container/s.
  21. In case of active raw material withdraw about 1 gm of sample from every selected Container / Drum in separate sampling bag, for Identification test. With draw the sample using sampling rod. When container is small then use spatula for sampling.
  22. Withdraw the sample from all selected Containers/Drums by sampling rod in sample bag to get desired quantity. Seal the sampling bag, properly mix it to get homogeneous for composite sample and affix label “Sample for analysis” on it.
  23. Divide composite sample in three parts.
  24. Sample for analysis.
  25. Sample for control sample.
  26. Sample for out lab analysis.
  27. Affix “UNDER TEST” label on the Quarantine Label.
  28. Affix ‘SAMPLED’ label with sign & Date on container from which sample is drawn.
  29. After Completion of sampling activity, tie the bag with the help of Nylon thread / cable tie and close the container/drum/bag properly.
  30. Ensure thorough cleaning of sampling booth after sampling is over.
  31. Switch ‘OFF’ the sampling Booth after sampling and inform to the store person to shift the consignment in Under Test area.
  32. Fill the sampling log book after completion for sampling activity & cleaning activity.
  33. Fill up the Raw material sampling sheet as per Annexure II.
  34. Exit from store department according to given procedure.
  35. Enter in Q.C. laboratory through change room following entry procedure and bring the individual test sample & composite sample in Q.C for analysis.
  36. If material fails in Identification test then sample the material from each & every container of consignment.
  37. After entering in QC lab, one should make entry in RM Sampling Inward Register.

 

FREQUENCY:

Every time new consignment is received.

ANNEXURE:

 

Annexure I: Consignment Check list.

Annexure II: Sampling Sheet.

 

Annexure – I

Check List for checking consignment Before Sampling for Raw Material

Sr. No. DescriptionRemark
1.Name of the Product / Material. 
2.Name of the Manufacturer. 
3.Name of the Supplier. 
4.Batch No. 
5.Batch Quantity. 
6.Packing Size. 
7.Total No. of Drums / Bags Received. 
8.Quantity of drums with respect to Lower & Upper metallic ring and condition of fiber board lid.Ok / Not OK

9.Condition of bag.Ok / Not OK
10.Condition of containers and seal integrityOk / Not Ok
11.Cross check of label with GRN for Batch No. / Mfg. Date / Exp. Date. / Packing size.Ok / Not OK
12.Storage Temperature condition if any.Applicable / Not Applicable

OK / Not Ok

13.Check the party name on the Drum / Bag.Ok / Not OK
14.Whether material received along with Food Grade Certificate? (Yes/No)

If No action taken

 
15.Special observations if any. 

 

Checked By:                                                                                                    Date:

 

 

 

Annexure – II

Sampling Sheet for Raw Material 

Name of Material:-
GRN Details 
Name of material
GRN No.
Date:-
Challan  No.
Date:-
B. No. / Lot No.
Specification (USP/BP/IP/ in house)
Name & adress of manufaturer
Name & adress of suplier
Date of Manufacturing
Date of Expiry
Total quantity received
Lable details
Name of material
B. No. / Lot No.
Specification(USP/BP/IP)
Name & adress of manufaturer
Date of Manufacturing
Date of Expiry
Packing size
Sampling activity
Sampling Criteria (100% or As per √n + 1)
No. of Containers sampled
Any other observation
Quantity sampled
Sampled by
Date:-
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