SOP on sampling procedure of packaging material

SOP on sampling procedure of packaging material


  • To lay down the procedure for sampling of Packaging material.


  • This SOP is applicable to sampling of packaging material at


  • Chemist or above of Quality Control is responsible for sampling of Packaging Material.


  • Head – Quality Control

Procedure:Packaging material

  • Packaging material sampling shall be initiated after receiving the “GRN” from warehouse.
  • QC personnel shall enter the material details in Packaging material control register as    per Annexure No.A01 and allot A.R. No.
  • QC personnel shall generate labels of “SAMPLED” as per Annexure No. A08.
  •  QC personnel shall generate labels of “UNDER TEST” as per Annexure No. A09 The no. of “UNDER TEST” labels shall be ‘no. of container(s) + 1’.
  • QC personal shall go for sampling along with sampler’s report of packaging material as per Annexure No.A02 .
  • The separate sampler’s remark shall be used for each lot of batches.
  •  QC personnel shall check the materials as per GRN.
  • QC personnel shall have to ensure that “Quarantine” labels are affixed on each unit pack by warehouse department.
  • Fill the necessary details in sampler’s check list by taking the reference of goods receipt note (GRN).
  • Ensure that the surrounding area is clean, if not get it cleaned, prior to start of the sampling.
  •  Check the packing condition of the material.
  • Ensure that packs are cleaned externally and open the packages only after ensuring    the proper cleaning. Observe the material for any abnormalities and record it on the Sampler’s report of packaging material.
  •  In case of primary packaging materials like foil / PVC / vials & rubber plugs, sampling    person shall be wear the hand gloves & mouth mask to withdraw the sample for analysis and sampling shall be done under LAF.
  • In case of Pre sterilized flip off seal, sampling shall be done by Microbiologist under LAF of Aseptic area sampling booth.
  •  If no. of container / boxes are 5 or less than 5, then all container / boxes shall be sampled. If no of container /boxes are more than 5 then withdraw the samples randomly by opening different containers / boxes as per √n +1 rule, .where n is number of containers received in one lot.
  • 100 % sampling shall be carried out in case of Plain aluminum foils, Printed aluminum strip / blister foils, PVC, PVDC Films.
  • Sample quantity for analysis shall be taken as per Annexure No.03 . Put the sampled quantity in self-sealing polybag bearing the label of “SAMPLE FOR ANALYSIS” attached as per Annexure No. 04 .
  • After completion of sampling the material pack shall be resealed with BOPP tape or tied with the help of cable – tie and affix self-adhesive label of “SAMPLED” as per Annexure No. 08
  • Affix self-adhesive label of “UNDER TEST” on all container of that batch.
  • Carry out testing of the packaging material as per the laid down specification of respective material.
  • The sampling procedure described above will not be applicable for tertiary packaging material like shipper, pad, partition and corrugated trays. For these materials only one unit shall be collected, affix “SAMPLED” label and carry out the analysis as per laid down specification.

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List of Annexures / Formats



Format Title Annexure


1 Packaging Material Control Register A01
2 Sampler’s Report of Packaging Materials A02
3 Sample Quantity from Each Box/ Roll A03

 References (if any).

Reason for Revision

For better cGMP & cGLP


  •  cGMP             : Current Good Manufacturing Practice
  •  cGLP               : Current Good laboratory Practice
  • QC                  : Quality control
  •  SG                   : Sub General

Annexure 1

Packaging Material Control Register



   Date  Name of  Material Manufacturer

/ Supplier Name


/ Date



No. of



 A.R. No.

/ Date







by/ Date

Date of   analysis Date of completion


Status Analyzed by / Date Remarks

Annexure 2


1.      Name of material :       
2.      Name of manufacturer / supplier:
3.      Item code: 4. GRN No.:
5. No. of packs / boxes received: 6. No. of packs / boxes sampled:
7. Quantity per box / pack: 8. Quantity sampled:
8. Total quantity received: 9. Date of sampling:
Physical condition of consignment
10. Nature of containers Wooden/ polythene bag / gunny bag / paper bag / corrugated others…….………………
11. Physical condition of consignment Ok/ Not OK  (torn / seal open / damage)
12. Source of material Approved vendor / other
13. Analytical Report (COA) Received / Not received
14. Cleaning of surrounding area of consignment Ok/ Not OK
15. Proper consignment label affixed by party Yes / No
16. Proper Quarantine  label affixed by warehouse Yes / No
17. Mixing of material Yes / No
18. After sampling resealing of boxes done Yes / No
 19. Remarks:
Sampled by:

(sign / date)   


Annexure 3

Sample Quantity from Each Box / Roll

Sr. No. Name of Material  Sample Quantity
1 Glass ampoules 10 Nos.
2 Glass bottles 5 Nos.
3 Cartons 5 Nos.
4 Catch box / catch cover for physician sample 5 Nos.
5 Plain aluminum foils 1 meter from each roll
6 Printed aluminum strip / blister foils 1 meter from each roll
7 PVC, PVC/ PVDC Films 1 meter from each roll
8 Pack inserts / literatures 10 Nos.
9 Labels 10 Nos from each roll
10 Plastic bottles/container 5 Nos.
11 Pilfer proof caps 10 Nos.
12 Rubber plugs 10 Nos.
13 Tear off / flip off seals 10 Nos.
14 Glass vials 10 Nos.
15 Corrugated shipper 01 Nos.
16 Hips tray 05 Nos.
17 Shrink / LDPE bag 05 Nos.
18 BOPP/CELLO tap 01 Nos.
19 Shrink /stretch film 02 meter from sampled roll
20 Shipper label 10 Nos.
21 HDPE drum 01 Nos.
22 Silica pouch 20 Nos.
23 Hologram label 10 Nos.


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