Drugsformulations
SOP on sampling procedure of packaging material
Objective:
- To lay down the procedure for sampling of Packaging material.
Scope:
- This SOP is applicable to sampling of packaging material at
Responsibilities:
- Chemist or above of Quality Control is responsible for sampling of Packaging Material.
Accountability:
- Head – Quality Control
Procedure:
- 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
| S. No. | Format Title | Annexure Number |
| 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
Abbreviation:
- cGMP : Current Good Manufacturing Practice
- cGLP : Current Good laboratory Practice
- QC : Quality control
- SG : Sub General
Annexure 1
Packaging Material Control Register
| Sr. No. | Date | Name of Material | Manufacturer / Supplier Name | GRN No. / Date | Quantity Received | No. of Containers
| A.R. No. / Date | Work- sheet No. | Sampled Quantity | Sampled by/ Date | Date of analysis | Date of completion
| Status | Analyzed by / Date | Remarks |
Annexure 2
SAMPLER’S REPORT OF PACKAGING MATERIALS
| 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. |
