The pharmaceutical packing materials handling procedure ensures the safe and efficient handling of all packaging materials used in the production of pharmaceutical products. Our strict adherence to industry regulations and best practices guarantees the integrity and quality of the materials, ultimately contributing to the safety and efficacy of the final pharmaceutical products.
Receipt and Storage of Packing Materials
1.0 Purpose
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- To lay down the procedure for Receipt & Storage of Packing Materials in Stores.
2.0 Scope
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- The SOP is applicable to the Receipt and Storage of Packing Materials at the pharmaceutical drug manufacturing plant.
3.0 Responsibility
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- Store Personnel: Receipt and handling of Packing Materials.
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- QC Personnel: For Sampling and Affixing Under Test, Sampled, Approved & Rejected Labels.
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- QA Personnel: For discrepancy verification if observed during receipt of packing materials.
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- Head Stores: To ensure the compliance of SOP.
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- QC Head: To ensure for sampling and affixing Under Test, Sampled Approved & Labels.
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- Head QA: Handling of Non conformity if observed during receiving of Packing Materials.
4.0 Procedure for Handling of Packing Material in Pharmaceuticals
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- After receipt of information from the security gate store personnel shall allow the vehicle at the respective receiving bay.
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- Driver shall hand over the paper to store personnel at the document receiving window, after receipt of the Vendor’s challan/document check for the Security Stamp with entry number.
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- If Stamping is not done get the same done from the Security department.
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- Check the vendor’s challan/document for Purchase Order No. and verify the same with the Purchase order in the electronic system as per the Approved Vendor List. If not ask for the same from Purchase Department and Q.A.
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- Unload the material on the pallet & check the cleanliness of the bag/box.
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- Remove the secondary packing used if any and clean with a dry lint-free duster. If required use the vacuum cleaner for cleaning.
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- Verify the quantity of Packing Materials received as per challan and give acknowledgment by putting the stamp on the front of the challan/document
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- In case of material received is in short / damaged condition inform to Quality Assurance & Purchase Department and write a note on GRN.
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During the receiving of the printed cut label counting verification shall be done as per SOP.
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- Take the one bundle of printed cut labels & one roll of printed sticker labels for random counting from each box/pack and the record shall be updated in Annexure -I.
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- Carton counting shall be done on a random basis and record the observation in Annexure-I.
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- During receiving of foils / PVC store personnel shall check the details as per Annexure-II and record the observation.
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- Store personnel shall perform the net weight verification for the PP cap on a random basis. If the difference in net weight (more than 0.25%) of inner packing is observed then the actual observed weight shall be recorded in the system and record the observation as per Annexure-IV.
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If the vendor is new follow the above for each pack/container.
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- If the received quantity is not as per challan / Invoice, immediately inform to purchase department via phone/mail and GRN shall be prepared as per actual receipt qty.
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- Clean the packs/boxes externally with a lint-free duster at the time of stacking them on pallets/racks. Move the goods to per storage location of packaging materials.
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- After verification and entry into the Electronic system, the store officer shall print the “Goods Receipt Note”.
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- During preparation of GRN of all packing materials, Invoice No. / Challan No. shall be considered as Batch No. of received materials if the Batch No. is not provided by the Manufacturer.
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- Send duly checked and signed copies of GRN to the Quality Control Department for sampling of packing materials.
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- Store Personnel shall prepare White Quarantine labels and shall affix them as per the given below Plan:
Type of PM | Location of Quarantine Label | Status Labeling plan |
Bottle / Jar | Right side to the Product label | At least two labels per pallet one on top & other at the bottom. |
PP Cap, Measuring Cap, Dropper, Printed Material | Right side to the Product label | 100 % |
Alu Alu Foil, Printed Aluminum Foil, Plain Foil & PVC / PVDC | On the outer poly bag | 100 % |
C-Box | On Pallet / Bag | One label on Each pallet |
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Sampling of Packing Material:
- After receipt of GRN, the QC Chemist shall print the yellow colored Under Test label and shall affix the duly signed Under Test label just below the Quarantine label.
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- The chemist shall sample the packing material as per “ Sampling of Packing Materials” and paste the duly filled fluorescent yellowish green colored “SAMPLED” label on the right top corner of the UNDER TEST label on the container from which the sample was drawn.
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- After sampling place the consignment to the designated area.
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- After analysis, Q.C. chemist shall follow the procedure:
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Approval of Packing Material:
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- If the packing material is approved then the Q.C. chemist shall affix a green colored “Approved label” on the “Under Test” label of each container in such a manner that only “Under Test” is hidden by the next label of packing materials.
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- For Printed Aluminum, Plain Foil, Alu Alu Foil & PVC / PVDC rolls, one additional small-size Approved label shall be printed and affixed to the core of each roll.
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- After approval store personnel shall transfer the material to the respective approved area.
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Rejection of Packing Material:
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- If the material is rejected then the Q.C. chemist shall affix a red colored “Rejected “ on the “Under Test” label of each container in such a manner that only “Under Test” is hidden by the next label.
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- Record the details of rejected materials in the log book in the Rejected Room.
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- Store personnel shall shift the material in the rejected room in the presence of Q.A. and handle the material as per the direction of Head Q.A.
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- Store personnel shall make entries in the Rejected Log Book, placed in the rejected material room.
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- Record the temperature of the storage area(s).
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Important Instruction for Handling of Packing Materials:
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- Storage of printed packaging materials in specified areas.
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- The label shall be stored in a separate Almirah / Rack under lock and key.
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- If there is a printing problem then fill in the details under-test label using a ball pen (blue ink) and affix the label to the container.
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- Approved material shall be stored in a rack / Pallet A.R. Number and the status board shall be updated.
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- All PVC and Foil shall be covered with a clean poly bag and cable tie.
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- If required material shall be segregated using the physical separator.
5.0 Annexure (S)
Annexure – I: Physical & Quantity Verification of Cut Labels/Sticker Labels and Carton.
Item Name: ………………………………. Quantity: …………………………………
No. of Box/Pack: …………………….…. L. R. No. / Date: ………………………….
DC / Invoice /No.: ………………….……. DC / Invoice /Date: …………………..….
Supplier Name: ……………………….… Manufacturer Name: …..……………….
Box No. / Pack No. | Supplier ClaimQuantity | *Observed Quantity | Received No.of Bundle | Observed Quantity of Bundle X Total Received of Bundle | Remarks |
1 | |||||
2 | |||||
3 | |||||
4 | |||||
5 | |||||
6 | |||||
7 | |||||
8 | |||||
9 | |||||
10 |
*Remarks: One bundle/roll is to be taken for random counting from each box carton counting shall be done on a random basis and calculation shall be recorded in the above format.
Annexure – II: Physical & Quantity Verification of Foil / PVC Film.
Format for Physical & Quantity Verification of Foil / PVC Film
Item Name:……………………………………………. Quantity:………………………………………
No. of Containers:…………………………………. G. R. No. /Date:………………………………
DC / Invoice No. /Date:……………………………. L. R. No. / Date:………………………………
Supplier Name:……………………………………..
Manufacturer Name:………………………………. Type of Packing:…………………………….
Container No. / Pack No. | Physical Condition | Gross Weight (Kg.) | Core Weight
(Kg.) |
Net Weight
(Kg.) |
1 | Properly Packed / Damaged | |||
2 | Properly Packed / Damaged | |||
3 | Properly Packed / Damaged | |||
4 | Properly Packed / Damaged | |||
5 | Properly Packed / Damaged | |||
6 | Properly Packed / Damaged | |||
7 | Properly Packed / Damaged | |||
8 | Properly Packed / Damaged | |||
9 | Properly Packed / Damaged | |||
10 | Properly Packed / Damaged |
Remarks: The observed values are WITHIN LIMIT / NOT WITHIN LIMIT.
Annexure – III: Flow diagram for Receipt, Storage, Identification, and Movement of Packing Materials.
Annexure – IV: Weight Verification of PP Cap (Packing Material)
Item Name: | Item Code: | |||
Invoice Qty: | Total No. of Boxes: | |||
Supplier Name: …………………………………………….… | DC / Invoice /No.: …………………………….…. | |||
Sr. No | Weight | Difference | Remarks | |
Supplier Claim Weight | Observed Weight | |||
01 | ||||
02 | ||||
03 | ||||
04 | ||||
05 | ||||
06 | ||||
07 | ||||
08 | ||||
09 | ||||
10 |